ML20210R775
| ML20210R775 | |
| Person / Time | |
|---|---|
| Issue date: | 08/11/1997 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20210K626 | List: |
| References | |
| FRN-62FR42219, RULE-PR-35 PROC-970811-01, PROC-970811-1, NUDOCS 9709030323 | |
| Download: ML20210R775 (52) | |
Text
{{#Wiki_filter:. . . ._ - - - - - . o , August 11,1997 WORKING DRAFT UNSEALED BYPRODUCT MATERIAL - HIGH DOSE RADIOPHARMACEUTICALS FOR THERAPY. NOTE Following Commission approval of the staffs program to revise 10 CFR Part 35 and associated guidance documents, the NRC staff initiated development of draft rule language, using a modality-based approach. These draft modalities are being provided to the Part 35 Working Group at a very early stage in their development because they are key to the discussion of significant issues associated with the regulation of the medical use of byproduct material, which is an agenda item at the August 19-20 meeting of the group. It should be noted that at this point in their development that they have not undergone a thorough review, including a review to ensure that they reflect the Commission's direction. In fact, in some cases, the draft documents contain different alternatives to regulation of a specific area; Hopefully, these differences will stimulate input and additional alternatives from the Working Group.
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g90g323.970818 35 62FR42219 PDR
L AUGUST 11, 1997 UNSEALED BYPRODUCT MATERIAL ' WORKING HIGH DOSE DRAFT PART 35--MEDICAL USE 0F BYPRODUCT MATERIAL UNSEALEDsBYPPRODUCE@TERIALEHIGH; DOSE , RAD 10 PHARMACEUTICALS?FORETHERARY (INCLUDINGsDIAGNOSTICiSTUDIES? INVOLVING?DOSAGEST0E S00IUMi1001 dei [E13111NiOUANIITIES; GREATER;THAN;30jMICROCM8IES1 Subpart A--General Information . . . . . . . . . . . . . . . . . . . 3 Section 35.1 Purpose and scope . . . . . . . . . . . . . . 3 Section 35.2. Defi nitions . . . , . . . . . . . . . . . . . 4 Section 35.5 Maintenance of records . . . . . . . . . . . 10 Section 35.6 Provisions for research-involving human
; subjects ....................... 11 Section 35.7-FDA, other Federal. and State requirements . 11 Section 35.8 Information collection requirements::0MB
-approval. ....................... 11 Section 35.11 License requi red . . . . . . . . . . . . . . . 12 Section 35.12 Application- for license, amendment. or renewal . . . . . . . . . . . . . . . . . . . . . . . . -
13 Section 35.13 License amendments . . . . . . . . . . . . . 13 Section: 35.14 Notifications . , . .-.. . . . ... . . . . . 15 Section 35.15 Exemptions regarding Type- A specific-licenses of broad scope .................... 15 Section 35.18 License issuance . . . . . . . . . . . . . . 16 Section 35.19 Specific exemptions ............ 16-Subpart B--General Administrative Requirements . . . . . . . . . . . 16 Section 35.21 Radiation Safety-Officer . . . . . . .. . . . 17
NSEALED BYPRODUCT MATERIAL 2 August 11. 1997
. 'GH DOSE WORKING DRAFT
. Section 35.22 Radiation Safety Committee . . . . . . . . . 18 Section 35.23 Statements of authority and responsibilities 20 Section 35.25 Supervision ................ 20 Section 35.29 Administrative requirements that apply to the provision of mobile nuclear medicine-service ..... 22 Section 35MIdentifidationidf/,Prbg,hsht?.orsBrehstif6e,
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dingg, Sect ~ ion"35.31 Radiation safety program changes . . . . . . 22 Section 35.32 Quality management program . . . . . . . . . 23 4
-Section 35.33 Notifications, reports, and records ef mi: administrations foria]reportabls]medicaEevent . . . 26 Subpart C--General Technical Requirements ............. 29 Section 35.50 Possession, use, calibration, and check of dose calibrators ................... 29 Section 35.51 Calibration and check of survey instruments 30 Section 35.52 Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides . . . . . . . . . . . . . . 31 Section 35.53 Mcacurement Deteminat'ioh of dosages of unsealed byproduct materiaT^for msdical use . . . . . . 32 Section 35.57 Authorization for calibration and reference sources . . . . . . . . . . . . . . . . . , , . . . . 34 Section 35.59 Requirements for possession of sealed sources and brach" thera ^" cource ............... 34 Section 35.6'6 Shiefdingisnd2bbplingiof?vih15MhdTs)=rihgE5 cm + m wwsa vamvr - - - ^ ~
36 Secijos"3s.id'suseyFr Fasntam16ation'ahd ambieht radiation ex30sure rate . . . . . . . . . . . . . . . . 37 Section 35.75 Release of individuals containing radiopharmaceuticals or permanent imphnt . . . . . . -39 Section 35.80 Technical reguirements that apply to the provision of mobile nuclear medicine service ..... 40 Section 35.90 Storage of volatiles and gases . . . . . _. . 41 Section 35.92 Decay-in-storage . . . . . . . . . . . . . . 41 Subpart FD--Radiopharmaceuticals for Therapy . . , . . . . . . . . . 42
~~Section 35.300 Use of unsealed byproduct material- for therapeuti c - admi ni strati on'(i ncl Ddi ng Rinfidosag65? of 56diDmji6didQ931BMUanti ti es1grgatgeithanJ30 ^ ,
microcuries) ..................... 42 Sectio 6~357310' Safety instruction ............ 43
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.o - UNSEALED BYPRODUCT MATERIAL 3 August 11. 1997 HIGH DOSE WORKING DRAFT Section 35.315 Safety precautions . . . . . . . . . . -. . 43 Section 35.320 Possession of survey instruments ..... 46 Subpart JE--Training and Experience Requirements . . . . . . . . . . 46
~Section 35.900 Radiation Safety Officer ......... 46 Section 35.901 Training for experienced Radiation Safety Officer . . . . . . . . . . . . . . . . . . . . . . . . 47-Section 35.930 byproduct Training (including diagnosticFstudies;for therape material i nvol vi ngTdosEgeFof4 sodi bmti odi de cI&l-31&i nt qua nti ti es greatenithan40 microcuries)~ . '. ^.' T. 7. ^ .~l . .. 47 Secti on1351931 ? Trai ni ngiforJ ora Radmi ni strati on?6fisodi um
~ 1 odi ne:131406 di agnosti ci studi esli nXdosagefgreater? thari 30 ' microcuri esyora fonitreatmenti of a hyp~erthy~roi di sm on'~
cardi'acidysfunctionT. ~.T.~ . ' ~ . . .~T' . . .'"' . T , 51 Secti on135!932 ETrai ni ngTfor? parsnteraTWdmi ni strati ore of phosphor 9sl-324foritreatrMntioftmyeloprol.iferative- ~
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di sorders corli ntracavi ta ryicancerW or) stronti um-897oh samdriume153;foritreatmentToff bonetmetastas'is7 .' .M , 51 Section 35i9331 Training ifor oraliadministrationiof iodine'-131Dforktreatme'ntfofithyrojdicarcinoma" . . . . . 52 Section 35;970 Training for experienced a'Uthorized users . 52 Section 35.972 Recentness of training .......... 53 Section 35.980 Training for an authorized nuclear pharmacist ...................... 53 Section 35.981 Training for experienced nuclear pharmacists . . . . . . . . . . . . . . . . . . . . . . 54 Subpart KF--Enforcement ...................... 54 "Section 35.990 Violations ................ 54 Section 35.991 Criminal penalties ............ 55 Section 35.999 Resolution of conflicting requirements during- transition period ............... 55 Subpart A--General Information Section 35.1 Purpose and scope. This part prescribes requireraents and provisions for the medical use of byproduct material and for issuance of specific
y l UNSEALED B ORODUCT MATERIAL 4 August 11, 1997 HIGH DOSE WORKING DRAFT licenses authorizing the medical use of this material. These-requirements and provisions provide for-the protection of the public health and safety. The requirements and provisions of this part are in addition to, and not in substitution for, others in this chapter. The requirements and provisions of parts 19, 20, 21, 30, 71. and 170 of this chapter apply to applicants and licensees subject to this part unless specifically exempted. Section 35.2 Definitions. Address of use means the building or buildings that are identified on the license and where byproduct material may be received, used, or stored. Agreement State means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954 as amended. ALARA (as low as rea:Onably achievabic) mcans making ever" rea:Onable effort to maintain ex to radiation as far below the donc limits as is practical.p0 ure (1) Consistent with the purpose for which the licensed activit" is undcrtaken. - Ghiaking into account the state of technolog", the economics ef-HQrovements in relation to benefits to the public health and safcty, and other 50cietal and 50cioeconomic considcrations, and (3) In relation to utilization of nuclear energy in the public interest. Area of use means a portion of an address of use that has been set aside for the purpose of receiving, using, or storing byproduct material. Authorized nuclear pharmacist means a pharmacist who is: (1) Board certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties: (2) Identified as an authorized nuclear pharmacist on a Commission or Agreement State license that authorizes the use of byproduct material in the practice of nuclear pharmacy: or (3) Identified as an authorized nuclear pharmacist on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the use of byproduct material in the practice of nuclear pharmacy.
C UNSEALED BYPRODUCT MATERIAL 5 August 11, 1997 HIGH DOSE WORKING DRAFT Authorized user means a physician, dentist, Or podiatrict who (1) Board certificd by at least one of the boards listed in Para ^raph (a) IMeets thefrecDirements of Section: 35.910, 35.920,
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- v. vs.ssv, vi (2) Is' 4 : identified as an authorized user on a Commission or Agreement State license that authorizes the medical use of byproduct material: or (3) Is 4 identified as an authorized user on a permit issued by a Commission or Agreement State s)ecific licensee of broad scope that is authorized to permit tie medical use of byproduct material, Brachytherapy 50urce means an individual scaled 50urce or a manufacturcr assembled cource train that is not designed to be disassembled b" the user Dedicatedcfiecksourcemeansaradioactivesourcethatisused to assure the constant operation of a radiation detection or measurement device over several months or years.
Dental use means the intentional external administration of the radiation from byproduct material to human being; in the
^ractice of dentistr'" in accordance with a 11cen:c issued by a state or Territory Of the United States, the District of Ceumbia. Or the C0=0nwcalth of Puerto Rico.
Dentist means an individual licensed by a State or Territory Of the United States, the District of Columbia. Or the C0=0nwalth of Puerto Rico to practice dentistry. Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures: where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration. Management means the chief executive officer or that person's delegate or delegates. Medical Institution means an organization in which several medical disciplines are practiced and?thhti_proil_ ids _siinp_atien_t gpg _ _
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/Gi A e si uAu4i vnnh s emsem i& 4 r s1 Anesnn iwwwi yii m niu w w w w i w u i uvau3w nrns+ nr +hsn wimi vu Ohnm4 i iernm w wu ir4 m iwsne sui ri f n4+har e riA 4 i im .4 n A 4 A n f 46.s iOC ne T 1 1 uhan h ei+ h i ava m ru i vv u i .
O i w i w iw i svuimu ivuius a vi a
/4\ Tkn sam T ii iin 4n4e+nenA AnesneruiA4ffnee u wn i s i i s w i wu uvsupw iiwe s i frnm i vo i +kn w rw neneee4knA yiwsw
,a ivwu uvsupw Anesnn hm m-m +hsn in nar,.an+ mf +hn nene,e4ha ursan wiru vj niv i w w im i av yw i w w i u vi w iw y1 u swi ivwu vvsuyw,
/44\ Thrs A4finennen ha&unan +hn sam 4n4e+nenA Ane snes snA siii iviw uii i w i w iw w uw wnw w i i w iw uwn iiii s wwi wu uvauyw w iu nereen4knA Anesnn n u e nrr A e 1C m4eeneine4ne, yiwww ivuu uvausw wnswwus av in i w i vwm iws, r r s A 4 anh, im srmi
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/s,A ,\ A t h .eir s nm i& 4. w w. iuuiy e
vi nA4 nam 4nA4AnmuT46.s 1OCvirs ea T 191 uhnn thn sMm4 n4 e + nre1A Anesan m iu i w iw uwn i i n i s wwi wu vvsupw svuiwn ivuiuw a ava, A4 fifare uii u -ifenm ii vin +hn w nene1w yi re4 www hnA ivsu An uvauyse s rin vj ho invimnen w wiiusi +hsn av inyw nner.nn& i w u i u nf +hn vi w iw nearer 4.hnA vwuAuvs n e .s a,n .. ri w swi (C\ A. & rsi nt heiru snuyj es A4 s+ 4 an Anen uhnn &hn e s1 riil s+ n d i v u i u w i vi i uvsw m iw i w is vuiwuiuwww nwn hi, ij o nest lu svi 1 w iw u n.
+hn unablo s e rse e r d k n A An e r, 1C s Am 4 n 4 e & n c es A Ari e r nuennAe uwn i v ii s vu wu uvsw wnwwwus w iw nwwn ij .n uswi ivwu uvsw vy m nacennt ne mnen af thn unablu m e n e r. r 4 sad Amen. vine vi nivi w vi w iw nwwn ij yi wsw i gwu uvsw, yw i w w i w
/f\
sviAri hescho&heirsno vi uw y w iu w yj i esA4st4ein uu i u s i vii uvsw Anenm uhan iw i w &ha iw wu e s il wu en iiluswu + riA
- sam 4nietnenA Amen A4ffare f, iram, thn n es e r e 4 hnA Anen hs # morn twim h s n, uwni11iswiwu uvsw uii iwis vu wn y r, w s w iwww uvsw vj i nv i w i n nacean& viaf wtha nracer4hnA iw yi w su ivwu uvsw.
Amen au 5wi ww iwealed source means any byproduct material that is encased-in a capsule designed to prevent leakage.or escape of the byproduct mater,ial,ym n+harsnm nh m e 4 ,. 4 e + m s m. +hn 4 a4 m4 us, 4Amn+4(4 a sc i i iv i v i uuu i i uw i w i i iwu us w iw
+hm n%m is w iw i w s w w iw i w yy yivsswisu 4-ni n & ha r s nm nhoe4e4e& rin s (%mm4, vvo n asswi e e 4 nn 1i 4,ennen w w ig w ,
tw i s w iw i w yj yivsiuisu vii u
. - - - . . , _ . , - _ , _ _ _ , , ,a -_ . . . , _ . _ _ _ , - _ -,
u 4 k UNSEALED BYPRODUCT MATERIAL 9 August 11, 1997 HIGH DOSE WORKING DRAFT Unit'dosagefmeansEa~ dosage? intended for.medicaliuse11nlai single patient"or human research subject that.has been obtained from a manufacturer or preparer licensed pursuantito 10 CFR 32.72 or equivalent; Agreement State gequirementsc Written directive means an order in writing for a specific patient or human research subiect, dated and signed by an authorized user prior to the administration of a ' radiopharmaceutical or radiation, exccat a; spccificd in
-paragraph (5) Of this definition- containing the following information:
(1) For any administration of cuantities greater than 30 microcuries of either sodium iodice I 125 or 1-131: the dosage; or t
' (2) For a therapeutic administration of a radiopharmaceutical other than sodium iodide I 125 or 1-131: the radiopharmaceutical, dosago,androuteofadministration6 (m) For ga=a stcr00 tact 10 rad 10 urg^r"; target c00rdinatos, collimator 5120, plug pattern, and tota 5 'do 0; (4) For-t010 therapy: the total-do 0, do c trcatm0nt sit 0, and Ov0rall tr0atm0nt ^^ri0d:per fraction, (5) For high-do;0 rat 0 remote aftcrf0ading brachytherapy: the radici 0 tope, trcat"'Ont sit 0, and total dosc; Or (5) For all other brachytherapy:
(1) Prior to implantation: the radici;0 tope, number of
- ources, and 50urc0 strengths; and (11) After implantation but prior to comp 10 tion of the proc 0 dure: the radici;0 tope, tr0atm0nt sit 0, and t0tal ;0urce strength and 0xposurc time (Or, Oguivalently, the total do 0).
[51 FR 36951, Oct.16,1985, : = ended at 56 FR 34120, Jul" 25, 1991,59FR61781,00c.2,1994;50FR18625,50pt.20,1998] Section 35.5 Maintenance of records. Each record required by this part must be legible throughout the retention period specified by each Commission regulation The record may be the original or a reproduced copy or a microform , provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear co)y throughout the required retention period. The record may also )e-stored in electronic media with the
i UNSEALED BYPRODUCT MATERIAL 10 August 11, 1997 , WORKING HIGH DDSE DRAFT ! l capability for producing legible, accurate, and complete records i during the reouired retention period. Records such as letters, ' drawings, specifications, must include all >ertinent information such as stamps, initials, and signatures. T1e licensee shall i maintain adequate safeguards against tampering with and loss of ; records. [53 FR 19247, May 27, 1988) Section 35.6 Provisions for research involving human subjects. - A licensee may conduct research involving human subjects using
- byproduct material provided that the research is-conducted, funded, supported, or regulated by another Federal Agency which
has implemented the Federal Policy for the Protection of Human i Subjects. Otherwise, a licensee shall ap)RC license before1y for and rece approval of a specific amendment to its V conducting such research Both types of licensees shall, at a minimum, obtain informed consent from the human subjects and obtain prior review and approval of the research activities by an
" Institutional Review Board" in accordance with the meaning of these terms as defined and described in the Federal Policy for d
the Protection of Human Subjects, [59 FR 61781. Dec. 2, 1994] i Section 35.7 FDA, other Federal, and State requirements. . Nothing in this part relieves the licensee from complying with applicable FDA, other. Federal, and State requirements governing radioactive drugs or devices.
.- [59 FR 61782, Dec. 2, 1994)
Section 35,8 Information collection requirements: 0MB approval. . (a) The Comission has submitted the information collection requirements contained in this part to the Office of Management
- - - . ..-. . , . . ,-.-,.,--..~.,.,....-.-.~,_,.-,-.-,_,r-_-.,,,,,-...-m.,,,.,-~,.,,-.....-..-,_.m. ...-m_. ,.- - - , -
UNSEALED BYPRODUCT MATERIAL 11 August 11, 1997 HIGH DOSE WORKING DRAFT and Budget (OMB) for approval as required by the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). OMB has approved the information collection requirements in this part under control number 3150-0010. (b) The approved information collection requirements contained in this 3 art ap) ear in Sections 35.6, 35.12, 35.13, 35.14, 35.21, i
-35.22 35.23, 35.29, 35.31, 35.50, 35.51, 35.52, 35.53, 35.59, ',
35.60, 35.61, 35.70, 35.80, 35.92, 35.204. 35.205, 35.310. 35.315, 35.404, 35.406, 35.410, 35.415, 35.606, 35.610, 35.615, 35.630, 35.632, 35.634, 35.636, 35.641, 35.643, 35.645, 35.647, 35.980, and 35.981, (c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection : requirements and the control numbers under which they are approved as follows: (1) In Section 35.12, Form NRC-313 is approved under control
. number 3150-0120.
(d) OMB has assigned control number 3150-0171 for the information collection requirements contained in Sections 35.32 and 35.33. [51 FR 36951. Oct. 16, 1986, as amended at 57 FR 41378, Sept. 10, i 1992: 59 FR 61782, Dec. 2, 1994) Section 35.11 License required. (a) A person shall-not-manufacture, produce, acquire, receive, possess, use, or transfer byproduct material for medical use except in accordance with a specific license issued by the : Cormiission or an Agreement. State, or as allowed in paragraph (b) or (c) of this section.
.(b)-An individual may receive. possess, use.-or transfer
__ byproduct material in accordance with the regulations in this chapter under the supervision of an authorized user as provided I
-in Section 35.25, unless prohibited by license condition.
(c) An individual-may prepare unsealed byproduct material for medical use in accordance with the regulations in this chapter under the supervision of an authorized nuclear pharmacist or
-authorized user as provided in Section 35.25. unless prohibited
UNSEALED BYPRODUCT MATERIAL 12 August 11. 1997 HIGH DOSE WORKING DRAFT by license condition. [51 FR 36951, Oct. 16, 1985. as amended at 59 FR 61782 Dec. 2, 1994] l l Section 35.12 Application for license, amendment, or renewal. (a) If the application is for medical use sited in a medical ! institution, only the institution's management may apply. If the & application is for medical use not sited in a medical
. institution, any person may- apply.
material(b) Anasapplication described infor a license for medical use of by35.100, Sections 35.A00, 35.20 and 35.500 of this part must be made by filing an original and one copy of Form NRC-313. "A) plication for Materials License." For guidance in completing t1e form, refer to the instructions in the most current versions of the appropriate Regulatory Guides. A request for a license amendment or renewal may be submitted as an original^ and one copy in letter format. cdical use of byproduct sc) , ne-applicaticn m s-4 ,, u,--4 sma for ' license 4., e m- + 4 m., for x cnn er +s4, ,, , - + m. , r + sm meu
's~ ~7H Ilm":. "CIM ";" Ca'IZ 'C "';7"Fmn 56'A"M "r',""~;m73,"~""
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"lEIFbPcohIesIffegulatoryguIdes,applicationforms,orto submit an application or an amendment request, refer to Section 30.6 of this chapter.
(ed) An applicant that satisfies the requirements specified in 10 CFR 33.13 may-apply for a Type A specific license of broad scope. [51 FR 35951, Oct. 15, 1985 :: ended at 59 FR 51782, Dec. 2, 1&nA7 s .r .r , 4 Section 35.13 License amendments. A licensee shall apply _for and must receive a license amendment:-
, 1 UNSEALED BYPRODUCT MATERIAL 13 August 11, 1997 HIGH DOSE WORKING
> DRAFT (a) Before it receives or uses byaroduct material for a clinical procedure permitted under t11s part but not permitted by l the license issued pursuant to this part: ) (b) Before it permits anyone to work as an authorized user or ! authorized nuclear pharmacist under the license, except an individual who is: ; (1) An authorized
.m,. m m,4 4m ,,-s,,,,a,user-certified-by,the, m a e~.u ~ enn organizations e ~. u ,m oc non ECIR;"se "n,f' EE.;C.,'46 Min"'E%;T'4 J"4E'M6n :'E", sCT46 '
"~
ncn i Ed10
~(2) 3An^ 5ts3fie authorized YegUIreE nuclear ~ntiIin $35330I" pharmacist ~ ~by' t~he certified organization specified in paragraph (a) of Section 35.980: i (3) Identified as an authorized user or an authorized nuclear pharmacist on a Commission or Agreement State license that
, authorizes the use of byproduct material in medical use or in the practice of nuclear pharmacy, respectively; or , (4) Identified as an authorized user or an authorized nuclear pharmacist on a permit issued by a Comission or Agreement State l specific licensee of broad scope that is authorized to permit the ! use of byaroduct material in medical use or in the practice of nuclear plarmacy, respectively. 1 (c) Before it changes Radiation Safety Officers er TeletAer-apy i 4 Physicists; , (d) Before it orders byproduct material in excess of the amount, or radionuclide or form different than authorized on the license: and , (e) Before it adds to or changes the areas of use or address or addresses of use identified in the application or on the license, [51 FR 36951. Oct. 16, 1986, as amended at 59 FR 61782. Dec. 2, ' 1994] Section 35.14 Notifications. (a) A licensee shall. provide to the Commission a copy of the-board certification, the Commission.or Agreement State license, or the permit issued by a licensee of broad scope for each. individual no later than 30 days after the date that the licensee permits the individual-to work as an authorized user or an authorized nuclear pharmacist pursuant to Section 35.13 (b)(1) . through (b)(4). 1 l
UNSEALED BYPRODUCT MATERIAL 14 August 11, 1997 WORKING HIGH DOSE DRAFT (b) A licensee shall notify the Comission by letter no later than 30 days after: (1) An authorized user, an authorized nuclear pharmacist; orf ~ l
"+"" ,
Radiation discontinuesSafety Officer,ofor performance telethera^f duties unde ihl 1cist permanently" license or has a ; name-change: or (2) The licensee's mailing address changes. (c) The licensee shall mail the documents required in this section to the appropriate address identified in Section 30.6 of - this chapter. [59 FR 61782. Dec. 2, 199A) Section 35.15 Exemptions regarding Type A specific licenses of broad scope. A licensee possessing a Type A specific license of broad scope for medical use is exempt from the following: (a) The provisions of Section 35.13(b): (b) The provisions of Section 35.13(e) regarding additions to or changes in the areas of use only at the addresses specified in the license: (c) The provisions of Section 35.14(a): and (d) The provisions of Section 35.14(b)(1) for an authorized . user or an authorized nuclear pharmacist. [59 FR 61782. Dec. 2, 1994) . f-Section 35.18 License issuance. The Commission-shall-issue a license for the medical use of byproduct material for a term of fi"c '" cars if: (a) The applicant has filed Form NRC-313 " Application for Materials License" in accordance with the instructions in Section 35.12: (b) The ap)licant has paid any applicable fee as provided in - part 170 of t11s chapter: (c) The Comission finds the applicant equipped and comitted to observe the safety standards established by the Comission in this-Chapter for the protection of the public health.and safety:
UNSEALED BYPRODUCT MATERIAL 15 August 11, 1997 HIGH DOSE WORKING DRAFT and (d) The applicant meets the requirements of part 30 of this chapter. Section 35.19 Specific exemptions. The Commission may, upon application of any interested person , or upon its own initiative, grant such exemptions from the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest The Commission will review requests for exemptions from training and experience recuirements with the assistance of its Advisory Committee on the Mecical Uses of Isotopes, Subpart B--General Administrative Requirements Section 35.20 ALAR ^,-program. (a) Each licensec shall develop and implement a written sA4s 4 an .yine fuuru+wivii A+ ^r+ 4 nn nennesm ths+ 4nrinAne nrno4c4nne_<nr bann4nn w www w i vii y1 vyium wiiu w i i rw i uww s yi v v i w i viis i vi nuw y v i vy An n e, ,Atm ,A,D A .-_ um,e w (b) To satisfy the rega&rement of paragraph (a) of this section:A+ s mnA 4 e s i 4nc+4+n&4nn msnsnaman+ +hn DsA4 s& 4 nn Cs<n&u
/14 siis wi ww wivii, mu s iu y wniw i i w , wiiw i m uiu wivis vu i w vy g4i riu u o vw u i v u i Officer, and-all authorized uscr; must participate in the program se +4nn Cs<n&o ramm4+&nn us ennone&nd. us iwywwsww ho +hn wivw im Ds tri vi i su i w vj vvmo iwwww.
(2) For licensec that are not medical institutions, management and all authorized uscr; must participate in the nemnesm ,, ranmac+mA hm +hn DsA4s+4mn es<n+m nr<4-me vi i iwwi . pi v um us iwywwawww uj wuw nuwiuwivo vu i w wy sc) The program must include notice to worker Of the program'; cxistence and workers'n<mmsr4neresponsibility s r no 4 au, ci n< +hn + unne to help unA keep sman in+ do c0 nni w v ii4v 0 usi lwiiu an+s c ,Alwivv A D A,, u i wv i w v1 vi suurnui i ww vi wiiw w ywa wiiu u mvu i i w s 0, bypr0 duct material used. Occupat10nal dose", civanges in a es<n+m -si~mm.s. o.rne .e im n Aw evim in w+ 4i ni m. 4 nn, e s A 4 .s + iwui . i4 vi mn, .e .s i <m+ w ., mrin vw e mwe n A. m. .. e n e.s n, m e u . w ., iw, i iii ed" cation-and training for all per:Onnel who work with or in the v4:inity of b" product material. The ;urp0"0 Of the review is to ensure that licensec; ke a rea:Ona lc effort to maintain 4simn A 4, u, iv ui4 A.u sui1msnA .en11nn+4un vi is. i1w nn_e v n n.ru s + 4 nn, iv ms1i Anene uv. .Am l .A.D.A. . Section 35.21 Radiation Safety Officer. fp r- g w vgy-..s y e y -m - g .,y - w-- m-
I UNSEALED BYPRODUCT MATERIAL 16 August 11, 1997 WORKING HIGH DDSE l DRAFT (a) A licensee shall appoint a Radiation Safety Officer ! responsible for implementing the radiation safety program. The , licensee, through the Radiation Safety Officer, shall ensure that radiation safet with approved )y activities are being performed in accorda , operation of t1e licensee's byproduct material program. (b) The Radiation Safety Officer shall: (1) Investigate overexposures, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, disposals, . m4Wministrations reportable < medical events, and other deviations from approved ~ radiation safety practice and implement - corrective actions as necessary:
-(2) Establish, collect in One binder or file, and im^1c=nt-written policy and procedures for :1mplementinglthe radiation ro safetp;utgram-(i , , morfi ing the purchase Of byproduct =terial:-
(ii) Receiving and Opening package: Of byproduct =terial: (iii) Storing by^roduct =terial: 44v) Keeping an Inventory record of byproduct =terial: (v) Usin" byproduct terial sfely: (vi) Taking emergenc=y action if control Of byproduct =terial i s lost-t-(vii) Performing periodic radiation surveys:
-(viii) Performing check: Of survey instru=nt; and Othee safety)ecuipment:
(ix Di ^^ ing Of byproduct =terial: : 4x)Trai8n;g^cr:0nnel who work in or frequent arcas where byproduct =teri51 is used or stored: (e3) Keep 4eg a copy of all records and reports required by the Conmission regulations, a copy of these regulations, a copy of each licensing request and license and amendments, and the written policy-and procedures required by the regulations, ; (34) Brief management once each year on the byproduct material program:
'E) Establish ^cr:0nnel expccure investigational level; that, w"en dxceeded, wi1T initiate an investigation by the Radiation Safet" Officer of the cause of the exp0 urc; (55) Establish ^cr:0nnel exposure investigational icvch that,
.when excccded, wilt initiate i prompt investigation by the Radiation Safet'" Officer of the cause of the exp0 urc and a c0nsideration Of action; that might be taken to reducc the probability Of recurrence:
--,,-c.o ww ,.._,,a,,., m,-,.. - - _ . - _ . , - . , . . . , . _,-...,m v- + - . , , -.,-.y,, r . ,- -
l i UNSEALED BYPRODUCT MATERIAL 17 August 11. 1997 HIGH DOSE WORKING DRAFT (67'::) For = dical use net-at a = dical institutionr aApprove or aredisapprove not potentially minorimportant changes to in safety radiation safet{c with tm advice andprocedures concent=0f anagement-: and (78) F0r medical use at a medical institut4en- aAssist the Radiation Safety Comitteeiiffone is' required lin the performance of its duties. . Section 35.22 Radiation Safety Committee. Each medical institution licensee shall establish a Radiation Safety Committee to oversee the use-of byproduct material. ' (a) Each Committee must meet the following administrative requirements: (1) Membership must consist of at least three individuals and must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is . neither an authorized user nor a Radiation Safety Officer. Other i members may be included as the licensee deems appropriate _. i (2) The Committee must meet at least quarterl minutes of each meetingEand maintain a copy the of y.cprepare minutos for the duration of the license. (3) The Committee-must have written-policies'andEprocedures
~
for conduct of its meetings-andibusiness to ensure'adeauate rogram.)To oversight Octabh sh of 3-quor0mthe licensee ind to sconduct radiation safety pJlcast business, t one half--Of tec C0=ittee's =mbership must be present, including the Radiation Safety Officer and the mana^cment's representative. (4) The minute: Of each Radiation !afety C0=ittec =cting must include: (1) The date Of the =cting: (ii) " embers 4iii) Member;present: ab ent-t
+1v) Su=ary Of deliberation; and- discussions; (v) Rec 0=cnded actions and the nu=rical result Of all ballots; and ,
(vi) ALAPA program reviews described in Section 35.20(c). . (5) The C0=ittec uct pro ptly provide cach 0-ber with a copy of the meeting minute;, and ret-a4n-ene copy for the duration of hc lkense. (b) To oversee the use of licensed material, the Comittee
UNSEALED BYPRODUCT MATERIAL 18 August 11, 1997 HIGH DOSE WORKING DRAFT must: (1) Review recommendations on ways to maintain individual and collective doses ALARA: (2)(1) Review, on the basis of safety and with regard to the training and-experience standards in subpart JE of this part, and ap3 rove or disa aut1orized user,pprove any individual who is to be 0 listed as an an authorized nuclear pharmacist, Radiation Safety Officer, or a teletherapy ^"ysicist~0 beforethe submittingalicenseapplicationorrequestloramendmentor
-renewal: or (ii)--Review, pursuant to Section 35.13 (b)(1) through (b)(4),
on the basis of the board certification, the license, or the permit-identifying an individual, and approve or disapprove any individual prior to allowing that individual to work as an authorized user or authorized nuclear pharmacist: (3) Review on the basis of safety, and approve with the advice
-and consent of the Radiation Safety Officer and the management representative, or disapprove minor changes in radiation safety procedures that are not potentially important to safety and are
' permitted under Section 35,31 of this part: (4) Review quarterly, with the assistance of the Radiation Safety Officer, a summary of the occupational radiation dose records of all personnel working with byproduct material: (5) Review quarterly, with the assistance of the Radiation Safety Officer, all incidents involving byaroduct material with , and resp6)(ect to cause Review annually, and subsequent actions tacen: with the assistance of the Radiation Safety Officer, the radiation safety program. [51 FR 36951, Oct. 16, 1986, as amended at 59 FR 61782 Dec. 2, 1994] Section 35,23 Statements of authority and responsibilities. (a) A licensee shall provide the Radiation Safety Officer, and at a medical institution the-Radiation Safety Conmittee,
-sufficient authority, organizational freedom, and management prerog')ative, (l Identify. to:radiation safety problems:
(2) Initiate.. recommend, or provide corrective actions:. and
~
19 August 11. 1997 UNSEALED BYPRODUCT MATERIAL WORKING HIGH DOSE DRAFT " (3) Verify implementation of corrective actions. (b) A licensee shall establish and state in writing the authorities, duties, responsibilities, and radiation safety activities of the Radiation Safety Officer, and at a medical j institution the Radiation Safety Committee, and retain the current edition of these statements as a record until the l Conmission terminates the license. l l Section 35.25 Supervision. l (a) A licensee that permits the receipt. possession, use, or I transfer of byproduct material by an individual under the . supervision of an authorized user as allowed by Section 35.11(b) of this part shall: (1) Instruct the supervised individual in the principles of - radiation safety appropriate to that individual's use of byproduct material and in the licensee's written quality management program: (2) Require the supervised individual to follow the instructions of the supervising authorized user, follow the written radiation safety and qual'ty management procedures
- established by the licensee, and comply with the regulations of this chapter and the license conditions with respect to the use of byproduct
/U Dnr4 nA4material: e s11 u rnu4nu and +hn e,innru4 enA 4 nA4 u4 Aiisl ' e iien nf smnZ, i ;s' Zr2,7,m,W si, ~'r i_C C, _sm""r L1;s"sm Cs " ~ H,nm" 4 w.7. e",:.
m ,m s. r m,7r(b) A licensee that permits the re aration of byproduct
. , ~ s. s material for medical use by an indi id al under the supervision of- an authorized nuclear pharmacist or physician who is an authorized user, as allowed-by Section 35.11(c), shall: ' (1) Instruct the supervised individual in the preparation of byproduct material for medical use and the principles of and procedures for radiation safety and in the licensee's written quality management program, as appropriate.to that individual's use of byproduct material:
(2) Require the supervised individual to follow the instructions given pursuant to paragraph (b)(1) of this section and to comply with the regulations of this chapter and license conditions: and (3) Require the super"ising authorized nuclear-phar =cist or
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UNSEALED BYPRODUCT MATERIAL 20 August 11, 1997 HIGH DOSE WORKING DRAFT physician who is an authorized user to periodically review the work ctf-the-supervised individual as it ?crtains to preparing byaroduct material for medical use and tic record; kept to r0flect that wor 4-(c) A licensee that supervises an individual is responsible for the acts and omissions of the supervised individual. [51 FR 36951. Oct. 16, 1991, as amended at 56 FR 34121. July 25, 1991: 59 FR 61782 Dec. 2. 1994] Section 35.29 Administrative requirements that apply to the provision of mobile nuclear medicine service. (a) The Commission will license mobile nuclear medicine service only in accordance with subparts D. E and H of this part and Section 31.11 of this chapter. (b) Mobile nuclear medicine service licensees shall obtain a letter signed by the management of each client for which services are rendered that authorizes use of byproduct material at the client's address of use. The mobile nuclear medicine service licensee shall retain the letter for three years after the last provision of service. (c) If a mobile nuclear medicine service provides services that the client is also authorized to provide, the client is responsible for assuring that services are conducted in accordance with the regulations in this chapter while the mobile nuclear medicine service is under the client's direction. (d) A mobile nuclear medicine service may not order byproduct material to be delivered directly from the manufacturer or distributor to the client's address of use. [51 FR 36951. Oct. 16, 1986, as amended at 53 FR 19247. May 27, 1988] Sec.tioni35MIdentificationiof PregnantforLBreast-feeding Women The711c~enseeJshalV estab11sh'andlimplement polici'es?and
~
procedures to provide: reasonable assurancelthat -a' radiopharmaceutical will not be unintentionallyLadministeredi.to~a pregnantior; breast-feeding: woman.
i t August 11, 1997 UNSEALED BYPRODUCT MATERIAL 21 HIGH DOSE WORKING. DRAFT ! Section 35.31 Radiation safety program changes. ! (a) A licensee may make minor changes in radiation safety ' procedures that are not potentially important to safety, 1.0.. m4nisterial chan90s, that were described in the application for license, renewal, or amendment except for those c1anges in ; Sections 35.13 and 35.606 of this part. Ex=ple Of such , ministerial change include: editin" of precedurc for clarity or ! E0nfor=nce with local drafting policy or updatin^ n=cs, ; tele ^honc nu2 crc and addresses: adopt 10n Of "Od51 radiat10n l Safe [y procedures published in NRC Regulatory Guides: r0 place =nt i' nt, reassign =nt Of task =0ng c"p10yec : Or
- 0f assign =n Of service contract; for serv.ces such 0; per:0nnel equip =t .
i dO:i=try, radiation safety equip cnt repair or calibration ! waste di:^0 al and safety surveys. A licensee is res3onsible for , assuring that any change made is in compliance with t1e requirements of the regulations and the license. (b) A licensee shall retain a record of each change until the ! license has been renewed or terminated. The record must include the effective date of the change, a copy of the old and new radiation safety procedures, the reason for the change, a-cu=ary of radiation tter that were considered beforc = king the change. and.cty the =ignature s of the Radiation Safety Officern" and the signature Of .hc affected authoriacd users and Of
=nasc=nt Or in = dical institut10n, the Radiation Safety C0=1ttee's chair =n and the =nage=nt representative.
Section 35.32 Quality management program. (a) Each ap)licant or licensee under this-part, as applicable, shall establisi and maintain a written quality management program to provide high confidence-that byproduct =terial or radiation from ""^roduct =terial 'radi~opharmaceuticals will be administered as directed by the^authorizdd Os'er. The quality i management ~ program must include written policies and procedures to meet the following specific objectives:. (1)1That,
' prepared for: prior to administration, a written directive 1-/ is -
1 / It. because of the patient's condition, a-delay in. order to provide a written revision to an existing written directive- :
o : i . UNSEALED BYPRODUCT MATERIAL 22 August 11, 1997 ! i HIGH DOSE WORKING . . DRAFT i would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the ' oral revision is documented immediately in the patient's record ' and a' revised written directive is signed by the authorized user I within 48 hours of the oral revision. Also, a written revision to an existing written directive may ; be made fo.r any d4 agnostic or therapeutic ^rocedure radiophannaceuticalcadministration provided that the revision is : dated andl signed by"an authorized ~ user prior to the l 4 administration of the radiopharmaceutical dosager , the
" doce, the g =3 sterc0 tactic radictur^ cry 00:0, the brach"therap'docc.
teletberapy Or-the next telethera^y fractiond dose. .
- If, because of the emergent nature of the patient's condition, t a delay in order to provide a written directive would jeopardize
' the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is pre)ared within 24 hours of the oral directive, ^ (1)- Any te etierapy radiation dose: (ii) Any g3=0 sterc0 Lac-tic radicturgery rad 4t-40n doce; (iii) Any brach" therapy-radiati0n dose:- (-i-v i_) Any administration of quantities greater than 30 . microcuries of either sodium iodide I 125 09 l-131: or (v 11) Any therapeutic administration of a radiopharmaceutical, other than sodium iodide I 125 Os I-131: (2) That, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive: (3) That final ^1:n Of treatment and related calculations for brachytherap,", tclEthera y, and g = Sterc0 tactic radicturgery ' are in accor.ance with tic rc pective written directive:: (4 3) That each administration is in accordance with the written directive: and (6 is ide'4) That ntified andany unintended evaluated _ anddeviation
, appropriate from actionthe iswritten taken.directive
, w m. .
m m m. . ~ %. , ,_, _._ , ~ , . . (1) Devel0p procedures for and conduct a review of the quality
=nage=nt progr= including, since the last review, an cvaluation Of:
(1) A rc^resentative :=ple of patient and hu=n research subjectaddniptrations,
- _ . . = ,__ _ _._ ___
~. . - -- -- . - . . _ _ _ _ - .. _.__ - -.--- _. .-. _ _
- 23 Augus 997 ! UNSEALED BYPRODUCT MATERIAL HIGH DOSE ' DRAFT
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(db) The licensee shall retain: (1) Each written directive; and (2) A record of each administered radiati'on dose or radiopharmaceutical dosage where a written directive is required in paragraph (a)(1) above, in an auditable form, for three years after the date of administration, 4 ~, e + , , +hm u u h ,, u , m n e m, mso mnuns a t.i nnvu imA4f,4,.d+wiviesiv- wv wi n m quu i n u, s +wy ttf in > >w is w n~j m s n s rmmant nennrsm &n 4 ne ens e n & hrs n erm e s m ' e nf wi fe 4i e w4 1 nnewi rwy u yi nenu4 v v iuwu AnA mu i ru p wmw i i w y1 vyium wv iimiwusw wiew yi vyi um a AnernsenA Th rs i14ranenn chs11 thn winwnennesm'e yi vy i u affne&4unnr.re n i a si iwwivwimss -- is e4e rv nes w ww& w i w u sw . i n n.Drin i4w nn ies w si m i i s 1 Aff4rn fiern4eb i viiissii wi m thn mnA 4 (4 e s & 4 mvvi, i ww w i vii wv wi m wyyivyiiuww nn & rs tha snnennr4s&n LlD f' ni m iu y i vi iu i vii iww feh4n OA Asue sf&ne &hnvimnA 4 (4 r- s & 4 rtn hse harm msdn Niviiiin vu vuys u i wwi m .mvuii i w u w i vi i s iv s vw i i muww.
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suumiw vv wiis wyyivviiuww i n /TD OA f s mis 14 4 uumi msnsanmnnt sm us seyui nset nf &hn sv vi n vv.v u youi i vy euywun ii w nrrtnesm gi vy o vi vi n snn14 e st 4 an' far i vi s 14 f em e n snA 4mnlaman& u i i wwiisw wiiu thn nennesm i n nn n 4 c e i s s n ra n i my i wu % i i w wi m yi vyi um wyvii i s swuiiww
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4 UNSEALED BYPRODUCT MATERIAL 24 August 11. 1997 HIGH DOSE WORKING DRAFT appropriate NRC Regional Office in accordance with -10 CFR 30.5 by January 27. 1992 a written certification that the quality manage ent program has been impic ented alo^g with a copy Of the program.
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.u,a . Section 35.33 Notifications, reports, and records of misadministr-ation forta reportable medicalfevent.
(a) For a mi administration ; reportable medicalteVent : t (1) The licensee shall notify by telephone the NRC Operations Center 2 / no later than the next calendar day after discovery of the mica 5 ministration reportable medicalfevent . 2 / lhe commercial telephone number of the NRC Operations Center is (301) 816-5100. (2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the misadministration reportableimedical event. The written report must include the licensee's name: ee prescribing physician's name; a brief description of the event: why the event occurred: the effect on the -inmividual who rcccived the misadministration involved patient?or? human:research subject;whatimprovements"'are'needed^toprevent~ recurrence;and ~~
' actions taken to prevent recurrence? : whsther the 11cen:ce notified the indi/idual (or the individual's responsible relative Or guardian), and if- not. Wh" not: and if there was notification, what information was providc'd. The report must not contain the individual's name 'sr any other information that could lead to identification of the individual. To meet the requirement: Of '
thi; section, thc notification of the individual receiving the mi; administration may be made instead to that individual's responsible relative or guardian. When appropriate.
a e UNSEALED BYPRODUCT MATERIAL 25 August 11, 1997 WORKING HIGH DOSE DRAFT mc4,4se enA s,em ro\ Thn 14emnemn c h s, , nn+4(m ehn wi m rm iwiwii fm r,4 vii m, y s i w i wii wiiv wisv svi rim i iwwiisww siiw i i irvuiij nOt4fu i ij
+hnwe mi iniA iu4i u 4 Ai n siwwwi 1 ivuu i, rnen4u4nn iivy witha m4esAm4n4r+rs+4nn m misuumiiiisvi w wivii viaf +ha viiw g g m4n4c'egt4nn-n,o mi>>>swi vivm 1 v i 1stnr wwi
+hg11 vi n OAmi hna mv. t,r e s(+ne 4+c viswv wi r,u ,,,
a miwwi 1 .s A 4 e r nu. n , unless the refcFring= physician-per: Onall" informs the licensec either-tht he will infera-the individuai Or that, based-On mnA4es1 411A + +n114nn +hn 4 n A 4 u, suuui t- , --- w w i iiivy wi m i i iv i 4 Ai n uvuiv s 1 uniil uw A i kn1v h i sm rmfr i u i al . Tha iim mwuiwui g uus n+s i fii4 sw r e t.
+
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> i ww r isw w 4e nnt rnno4rnA &n nn+ 4 fu thm 4 nA4v iu4 is > >v u i wqu i 1 wu vv s iv w i ij wiiw iv idiw rsuvui sl u4nt ihni viivu if +hn enfn e r 4 nn .. nhyi oe 4 r 4 s n nn ij s i w i w i i vi eOnei r sn1 u i+ w i 4 inn +hn iwiwii ng wriv enfne rii nn iry. nhur 4 r 4 sn yrij siwivii. 4 i wiew iwivi i >>>3 the individual- receiving the misadministrat4cn-cannot be reached w&t-hin 24 hours, the licensec shall notify the individual as seen as-poss4ble-thereafter. The licensec may not delay any appropr4ste medical sarc ~for the individual, including any necessary-remedial eare as a result--Of the misadministration 1 beeauce of-any-delay in notification nn+4f4nA +hn 14cnnenn chs11 slen
/Ai s i ff 4hnvow4nA4u4Ans1 ai oae inuiv iuuus n s ovvii iwu, wow i iwuosww soui s uisv fornish, within 15-da" after disc,overy of the mitadministration-rmmar+ +m +4n s nu hmm a mru + mm i s. rv e w vv wi m 4,inimAi 4 m.
-, imii sv 4 A m mv i . h,m e mn A 4 nn, sumvim cohm4++nA w i wi m i .
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5 iis 1A. v- iwi uuswi 1 y v i vi v vi uv u i i wi m w wwiiw uivu consequences as they ma" affect the individual, provided a emhm4++md +n +hn noc -sn hn e+s+mmam+ 4r is 4 hi And i +4s+ muu viim w +sa wi menmnr+ i w rvi w v viii i w ww u vv wi m mi m vmii vs s um ww im m w obt44ned-from the licensec. (b) Each licensee shall retain a record of each m4sadmM4st+at4en reportable medical event' for 5 years. The record must contain the names of all individuals involved (including the prescribing ph sician, allied health personnel, the individuhl who received t ic misadmini + ration involved individual, and that individual's referring physician, if applicable), the 4ndividual's , involved patient s"or human research subject's social security number or other' identification number if one has been assigned, a brief description of the mi administration reportable medical event, why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence. (c) As4de from +he notification requirement, n Nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals receiving mi administrations" involved in^ reportable ~medicalEevbnts, or to that individual's responsibTe'relati' es"or v guardians.
. o 9
UNSEALED BYPRODUCT MATERIAL 26 August 11. 1997 WORKING HIG4 DOSE DRAFT [56 FR 34122. July 25, 1991, as amended at 59 FR 14086. Mar. 25, 1994: 60 FR 48626, Sept. 20, 1995] Cne&4nn St Ca inn 14 necivifar ensinA e ni i ren e nr Ant 14 rne far m^ A4rs1 aw w w i vi i vs.,AO e vuyy i i w i s swuiwu svuiwws vi ww1 iwws i vi n%uiwui A 14ennean mso n ic a #ne mnA m i i wwiisww n 1u y usw i vi 4 r s 1 inen nnlu. unuiwui usw vi e e y . Ano4rar ms niif sa tiirnA 1shninA n s e b sana __ Isi Cns1nA cs vu ru ii rC4es vi nr uw1 iwww inw e iu i u w w u i w u , iuvwiwu, yuwnupww. Tui swuiwu snA A 4 c + r 4 ki i& nA 4n sernrAsnan u4th s 14ranen 4 cissuwu rima eu e r r i i s n t +n yur v uuiiw vv uviu w i s wi iuwwwu siv uwwviuus1ww vi e w i i u i i wwiisw 1A PCD Dnet On snA 1.vA Pv.C D, v.O S ..,A7
> vi nr thn natw i4 viiw u s1 nn+ ra qu i v u i w i > w nii4 rn man + e nf
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t L UNSEALED BYPRODUCT MATERIAL- 27 August 11, 1997 HIGH DOSE WORKING DRAFT , Subpart C--General Technical Requirements ! Section 35.50 Possession, use, calibration, and check of dose calibrators. (a)TThisTs#ctibrirdoesrnot7aspliitoi0 nit ^dosagesTbfc photon-emitting radionuclidestthat are obtained:from a' ' <. manufacturer:or preparer licensed pursuant to110 CFR)32i72ioh equivalentj Agreement Stateirequirementsf' ~~ ~ '" ~ ~~ ~ ^ : (ab) A licensee shall possess and use a dose calibrator to ' measure the activity of dosages, exceptifor unit dosagesy of
. photon-emitting radionuclides prio'r to administration to each a patient or human research subject.
(bc) A licensee shall: (1) Check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. To satisfy the .
~
. requirement of this paragra)h. the check must be done on a ;
frequently used setting wit 1 a sealed source of not less than 10 microcuries of radium-226 or 50 microcuries of any other photon-emitting radionuclide: (2) Test each dose calibrator for accuracy upon installation
. and at least annually thereafter by assaying at least two sealed ,
sources containing different radionuclides whose activity the manufacturer has determined within 5 percent of its stated < whose activity is at least- 10 microcuries for activity,6 radium-22 and:50 microcuries for any other photon-emitting radionuclide, and at least one of which has a principal photon energy between 100 key and 500 kev:. (3) Test each dose calibrator for linearity upon installation
- and at least quarterly thereafter over a range from the highest i dosage-that-will be administered to a patient or human research subject to 1.1 megabecquerels (30 microcuries): and
- (4) Test each dose calibrator for geometry dependence upon
- installation over the range of volumes and volume configurations ,
for which it will be used. The licensee shall keep a record of- ;
~
-: this test for the duration of the use of the dose calibrator.
(c) A licensee shall. also perform appropriate checks and tests required by this section following adjustment or repair of the +
- dose calibrator.
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a i UNSEALED BYPRODUCT MATERIAL 28 August 11, 1997 ' WORKING HIGH DOSE ' DRAFT ; > (d) A licensee shall mathematically correct dosage readings for' any geometry or linearity error that exceeds 10 percent if the dosage is greater than 10 microcuries and shall repair or , replace the dose calibrator if the accuracy or constancy error i exceeds 10 percent. ' (e) A licensee shall retain a record of each check and test required by this section for three years unless directed i otherwise. The records required in paragraphs-(b)(1) through 4 (b)(4) of this section must include: 4 (1) For Saragraph (b)(1) of this-section, the model and serial number of t1e dose calibrator, the identity of the radionuclide '
- contained in the check source, the date of the check, the i activity measured, and the initials of the individual who performed the check:
(2)-For aaragraph (b)(2) of this section -the model and serial number of tie dose calibrator, the model and serial number of each source used, the identity of the radionuclide contained in the date of the test, the results of the the test, and the identity o the individual performing the test. source and its activity,f (3) For Jaragraph (b)(3) of this section, the model and serial number of t1e dose calibrator, the calculated activities, the measured activities, the date of the test, and the identity of I the individual performing the test. (4) For )aragraph (b)(4) of this section, the model and serial 4 number of tie dose calibrator, the configuration of the source : measured, the activity measured for each volume measured, the ' - date of the test, and the identity of the individual performing the test. . [51 FR 36951. Oct. 16, 1986, as amended at 53 FR 19247, May 27. r 1988: 59 FR 61783, Dec. 2, 1994) Section 35.51 Calibration and check of survey instruments. (a) A licensee shall calibrate the survey instruments used to ;
' show compliance with this part before first use, annually, and -
+
i
-following repair. The licensee shall:
(1) Calibrate all scales with readings up to 1000 millirem per -
. hour with a radiation source:
(2) Calibrate two separated readings on'each scale-that'must be calibrated: and - P g '- 9 '-ry<- q-tv ,,yyyTyry-= --w e y ve's -+y- m-qv'-gr'seirs +-syit- e-vrw+'wvy*=yr' u &vy->---'e- e.. .gSm. -w.'-qb @ we++ w.e'r--qme.-4-em. m m..e* ew%we m upme ecm t'--rP- 4--%wW.>=e-~Ev*----'-"-*d--* W-"?*'--"P9'
O i UNSEALED BYPRODUCT MATERIAL 29 August 11, 1997 , HIGH DOSE WORKING DRAFT (3) Conspicuously note on the instrument the apparent exposure rate from a dedicated check source as determined at the time of calibration, and the date of calibration. (b) When calibrating a survey instrument, the licensee shall consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent, and shall conspicuously attach a correction chart or h grap(c)to the instrument.A licensee shall check each survey instrument for operation with the dedicated check source each day of use. A licensee is not required to keep records of these checks. (d) A licensee shall retain a record of each survey instrument calibration for three years. The record must include: (1) A description of the calibration procedure: and (2) The date of the calibration, a descri) tion of the source used and the certified exposure rates from tie source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, and the signature of the individual who performed the calibration. [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988] Section 35.52 Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides. (a) This section does not ap)ly to unit dosages of alpha- or beta- emitting radionuclides; tlat are obtained from a manufacterer-or preparer licensed pursuant to 10 CFR 32.72 or mm ,4 ,, , un + A ri rnmsm n t C&s+n rnmi4 - n&c
~
MbObr 'o'EIirIhan unit dosagd"obtained pursuant to paragraph (a) of this section, a licensee shall possess and use instrumentation to measure the radioactivity of alpha- or beta-emitting radionuclides. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of al)ha- or beta-emitting radionuclides arior to administration to eac1 patient or human research su) ject. In addition, the licensee shall:
e , a ! UNSEALED BYPRODUCT MATERIAL 30 August 11, 1997 HIGH DOSE WORKING DRAFT (1) Perform tests before initial use, periodically, and following repair, on each instrument for acci"acy, linearity, and - geometry dependence, as appropriate for the use of the instrument; cnd make adjustments when necessary: and (2) Check each instrument to ensure fee constancy and proper ' operation'. at-4he-beginning of dach day cf ucc. [59 FR 61783, Dec. 2, 1994] Section 35.53 "caturement Determinatio'n of dosages of unsealed ' byproduct material for medical use, A licensee shal1+ determine 'andirecord the!activit dosagelatithe?timeL of admi ni stration . forc medi cal, use.;t o , (a) For'a unit dosage; this: determination may be'made ; either by direct-measurement' or by' a' decay correction, based on ' ~
~~
the measurement _made;bycthe 32,72: supplier: ~~ (b);Forja dosage"of a photonremitting radionuclide? prepared by the licensee, this determination-must be made c by, direct measurement: (c) Foria?dosageToffan alpha Cor3a?betafemitting radionuclidei made:by direct. prepared:by!the license,2thistdetermination'may ti. and g 1 (a) i,casure the activity O,f cach dosage of a photon emitting m-4 m- +m _a4-, , ,--
- s avi4, iuu m mu,w-in iuw a m yi i vi wv sim u i w u , usw, (b) "cacure, by direct =acurc=nt or by combination cf
=asurements and calculaticns, the activity of cach dosage Of an alpha or a beta emitting radionuclide prior to = dical use. .
except for unit dO ge: Obtained fro a manufacture" or preparcr licensed pursuant to 10 CFR 32.72 cr equivalent ?grec=nt State
,-,mm , 4, wii,-m -. + . ,, ,,
(ed) Retain a record of the =0;urc=nts ddterminations required by this section for three years. To satisfy"thi's' requirement, the record must contain the:
.- 1--,~--.-,*.-,-~ ewe.,,-wwm,---.r-- er--.rw--- Ir ~w.,-.m.w-- -w,--c -w , ,.-++-r- v gr% +.6
UNSEALED BYPRODUCT MATERIAL 31 August 11. 1997 HIGH DOSE WORKING DRAFT (1) Radionuclide? Ggeneric name, trade name, or abbreviation , of the ~radiopharmaceuticalr and its lot number, and expiration dates and the radionuclide: (2) Patient's or human research subject's name, and or ~~ identification number if one has been assigned: - (3) Prescribed dosage and activity of the dosage at the time l of mcature ent administration, or a notation that the total i s less than 1.1 megabecquerels (30 microcuries); and activity (4) Da te an,d time of the measu,rement1 me + sm w p , um ., mum administration! ; its im m e . m a^ 4"o-Feee W
. i r51 FR 35951. Oct.15,1985. : = ended at 53 FR 19247, May 27, I988: 59 FR 51784, Dec. 2, 1994] -
Section 35.57 Authorization for calibration and reference sources. Any person authorized by Section 35.11 of this part for i medical use of byproduct material may receive, possess, and use the following byproduct material for check, calibration, and reference use: (a) Sealed sources manufactured and distributed by a person licensed pursuant to Section 32.74 of this chapter or equivalent Agreement State regulations and that do not exceed 15 millicuries each: (b) Any byproduct material listed in Sections 35.100 or 35.200
- with a half-life not longer than 100 days in individual amounts not to exceed 15 millicuries
(c) Any byproduct material listed in Sections 35,100 or 35.200 with a half-life longer than 100 days in individual amounts not to exceed 200 microcuries each; and (d) Technetium-99m in individual amounts not to exceed 50 millicuries.
-Section 35.59 Requirements for possession of sealed sources.and twachytherapy courccc.
(a) A licensee in possession of any sealed source se I h- ,.,-- ,. .,-me,y. vmy- .,...----,.,-m. --- - , , , , - - - . . _ - . - - - . _..,.~--...m,. , . . - - , , - - , - - .< _
UNSEALED BYPRODUCT MATERIAL 32 August 11, 1997 HIGH DOSE WORKING DRAFT brach" therapy "ource shall follow the radiation safety and handling instructions supplied by the manufacturer, and shall maintain the instructions for the duration of source use in a legible form convenient to users. (b) A licensee in possession of a sealed source shall: (1) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within six months before transfer to the licensee and (2)-Test the source for leakage at intervals not to exceed six months or. at other intervals approved by the Conmission or an Agreement State and described in the label or brochure that accompanies the source. (c) To satisfy the leak test requirements of this section, the licensee must: i (1) Take a wipe sample from the sealed source or from the surfaces of the device in which the sealed source is mounted or stored on which radioactive contamination might be expected to accumulate or wash the source in a small volume of detergent solution and treat the entire volume as the sample: ,,mm,m- mu m, m rsum + m , m+ wm r , m , s.,a m+wm- am,pm e mm ~. m +m+
~^ " ~ ~
tho'50ur5c'15 Y t P off"~p33'1I1oEi'and (32) Measure the sample so that the leakage test can detect the p'resence of 0.005 microcuries of radioactive material on the
- sample, i
(d) A licensee shall retain leakage test records for five years. The records must contain the model number, and serial number if assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the measured activit of each test sample. expressed in microcuries, a descri ion of the method used to measure each test sample, the date o the test, and the signature of the Radiation Safety Officer.- (e) If the leakage test reveals the-presence of 0.005 microcurie or more of removable contamination, the licensee shall: (1) Immediately withdraw the sealed source from use and store it in accordance with the requirements in parts 20 and 30 of this ter:'and chap (2) File a re) ort within five days of the leakage test with the appropriate 9RC Office listed in Section 30.6.of this chapter, with a copy to Director, Office of Nuclear Material
UNSEALED BYPRODUCT MATERIAL 33 August 11, 1997 HIGH DOSE WORKING RAFT Safety and Safeguards, U.S. Nuclear Regulatory Commis /,on, Washington, DC 20555, describing the equipment involved, the test results, and the action taken. (f) A licensee need not perform a leakage test on the following sources: (1) Sources containing only byproduct material with a half-life of less than 30 days: (2) Sources containing only byproduct material as a gas:
-(3) Sources containing 100 microcuries or less of beta or gamma-emitting material or 10 microcuries or less of alpha-emitting material: and (4) Sources stored and not being used. The licensee shall, however, test each such source for leakage before any use or transfer unless it has been leakage-tested within six months before the date of use or,e mm nn e mma, a 4 .4 a 4 -
transfer an mm,mm - m ma; s.,d 4numm U II5Icensee'in 355s5ssidN"5Ia'5ehieIsou de"se brac!" therapy source shall conduct a quarterly physical inventory of ali such sources in its possession. The licensee shall retain
' each inventory record for five years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, and the signature of the Radiation Safety Officer.
(h) A licensee in possession of a sealed source se s ~ umam-smm e mm ~m sidiS7n5EsEEe thiainbient dose rates quarterly in all areas where such sources are stored. This doc not apply to teletherapy sources in teletherapy units-or scaled cource in diagnostie devices. (1) A licensee shall retain a record of each survey required in paragraph (h) of this section for-three years. The record must include the date.of the survey, a' plan of each area that was surveyed, the measured dose rate at several points in each area expressed in millirem per hour, the survey instrument used, and the signature of the Radiation Safety Officer. [51 FR 36951, Oct. 16, 1986, as amended at 52 FR 31611. Aug. 21, 1987:'53 FR 19247, May 27, 198S] . h.
._-.,w-, -4 my ..o --
I'm &--c- w r. >- #,m,,.mm,e-..~.amm,-., ..E,m.-.--, w%,.~ % m w .. c ...-,-,-.-,,---...----,&
4 r i August 11, 1997
- ' UNSEALED BYPRODUCT MATERIAL 34 :
HIGH DOSE WORKING l i
- DRAFT L
Section35.60Shieldinpn1e^and 51 abel i ngfofdi al sTandisy"pi nges Cur 4 ann eh4n1Ac 's nA 1 s
~ '"' j vyi i v ryw wii i w i vs ui m iuvwis.
i /s4 A 14ennean ehs11 wui o i i wwi nsww si ru i i bannnwwy syi cor4nnar &hst enn& s4 n h onugenAs i i ipw s wi iu v .,viiw u isi yi vwww ie+;- i 1 ms&nr4s1.&n euw w w i ivi kn sam 4n4efarnA 4nsii vv uw u uin i v i i s w w i w u s esA4s44nn u i uviuvivis sii i v i u . c h4 n1 A __ i
/ h \ . Tn 4 Ann &4fo.4&e enn&nn&e s 14ennean chs11 si vu i i enne nd riini te l o w vi is y a wwvw s i j Tui iv iwwiiwiif ivs w vi i wwii v s , u i wwiisww d
1shn1
>vvui nseh cor4 nan nr cor4nnn www e syi v i ipw vi syi 1,17 w rsA4s&4nn 1 u w i u w i vi r sis wiw c h 4, n 1 A &hww w.
st enn4-s4ne w vi i v w i i w w s
- or4nna u4 4- h n e s A 4 nnh s em s e ru it 4 e s 1. iim Thn 1shal me n e t ebnu viiw &hn
' bgi v i vyw vv i v i r u i u u i v yisu v uiu w w w w i w w iuwwi uuss s i iv ri l e s A 4 nnh s nm s e ru it 4 es siv iu nsma rw vi nriws 4&c shhrnu4 s& 4 nn &ha u uvi w v s u w i vi i .
el4n4es1 viiw wi iiiiwui i uu i vyv iu r inuwww w i w u i
- nerte nAs i en &n ha nn nemnA v i niw u ,
nr vi
+hn ns&4an&'e nr s vi
&hn wiiw h e iim s n ca e n s er.h n wu rw i s i w sww i wi r yi ww w uu r w vv uw yw viiw - yu w i w i i w riih 4 ne & ' e nsmn swugwww s v ivu n .
srnnsene s a
- le\
swi.m Ai14{nnean i wi isw w chs11 si vu ranii4 i i i wyu rninseh i w wwwii 4 nA4 o4 Ain si uh.n iimiviwwui m v s u w yu i w s u e sW 4 nnh s em s e ns i4- 4 r s 1 b44 &n s ie n s cor4 nan e sA4 s& 4 nn e ,4n1A uhan i uw i vy11u i n ew w w w w s w u i niw uv usw u - syi i i ryw i uu i u w i vi i s iiwiw m is i n nennsrJan &hn b4+ y1 w yu i tiry view niw wiiu s snA e k, , u iis11 caniid i i en nsch , i wyv w www i 4.11u i 1nA4 iuuui u4 Anwv isi usw
& rsws ie n s 1 eur4nna e s A 4 s t i an, ch4n1A uhnn sam u vui i4nd v i , e & nr 4 nn s e s A 4 nnh s emn eru i& 4 e s l ;
syi 1 113 w i uv i u w i vi s>>isiw m is i i sww. iivy u i u u i vyv iu s u nu w w w w i w u i ho 4 n 4ae & 4 nn inniner &hn e ie nwi af &hn ch4n1A 4e enn&rs4nA4rs&nA far up v i rgww w i vii vi v i w s s vi m usw vi m si v 1 w s u is wviivi u n i vu r ww w . u i vi ths& n 4nn&.ne hiamsn enensreh caih4 net ; b iu w - y iwivw vi i1uurvis i w ww ui wii suwgwww. 1
- l' t 1 [*D . Of oti && if loaf se smanAnA st CO CD c 1 va *7r0vA,. rine ')
- i. v 4 in vussai vww. av. 4 .< v v . us w u rw i m w w ww vs in www. w.
inoA1 ass a " (afLi'censeesTshaWinstruct?individuaTsMo1repare or
'administerc radiopharmaceutical1 radiopharmaceuticalsiinithe;properz vials and: syringesscontaining shielding;of byproduc .t material, andEin the= proper /use ofJsyringetradiation1 shields?
(b1 Licensee 3shallahave written: Dolic'essand:procedurestfor labeling of radiopharmaceuticalcvia'lstande syringestorf syringe ~ F radi ati on t shi el ds i. to mi. ni mi ze. s th.e r l i. k el_i h.ood r o_f er_ ror_s_L i n' "
- ad. mini,strations
+ _ + - y 5 n A vw w w i vi i ww.v4 1 iui sii s w i ws ui>w iuwwis. ,
I
?
/si A 14ennean eksil retni i 4 rn nseh 4 nA 4 o4 An is1 nennsr4nn ne sui o i i wsiisw w si vu i i i w yw7 i w www i s i iw i v iwwwi y i w yw i iivy vi .
hsnA14nn s ' 04 s1 & h. w .w enn& i mivvii,17 w v ivi st vi ww ii w sine w s e ww i n Ai4vyi nnhwsi ems iuw ww e ns w wi4- i v4ue, s 1 &n b rian +hn vv nwwy wi~ u4s1 4n s u4 si e s A4 s& 4 an .1. 4 m1 A y vui vii u v iui i u v iw wi viu si i i w i v . t#
- c ean&nnee s 14ennenn ebs)1 enne n4 en in,ie 11 A 4ivwiiu rdant 4 [i y l+u s w vi i v w i i w s , u i i ww isww wi iv i i uviw yiwwvwwig 1skn1 n 04s1 e s A 4 s 4- 4 an ch4n1A t h s4- enn4s4ne s ud s1 af s y iuwwi w ,- eini i u u v u w i vi i sii i w s u vi vu w w viiwu viis u viui vi w esA$ altbi .,enli&4es1 s . Th i i riw ishn1 ma i c & c hnui &hn e s Ai nish s em s r ni >4- 4 e n 1 i ww i vyi 1% wwwwiwwi iwwwi uvsw w i iv11 wi m i vu i vyi vu u sw w w w w i w u i I. ns-n ^r 4+e skhenu4 se 4 an i iwi > Tw vi iwa w uWi w1 iu u5viie.
~
v i i l 3 L. .> c , % m . ~ ,., - . , m_,..,n . - - - , , , - - - . _ - , . . , ...m.---...-~~-~...-...~~_.~.--.._...__--.-.__m--.--.,,,---.. --m
6 UNSEALED BYPRODUCT MATERIAL 35 August 11, 1997 HIGH DOSE WORKING. - DRAFT
.Section 35.70 Surveys for contamination and ambient radiation exposure rate.
(a) A-licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where . radiopharmaceuticals are routinely prepared for use or . administered.
-(b) A licensee-shall survey with a radiation detection survey instrument at least once each week all areas where
.radiopharmaceuticals or radiopharmaceutical waste is stored, n (c) A licensee shall conduct the surveys "equired by
-paragraphs (a) and (b) of this section so as to be able to detect
-dose' rates as low as 0.1 millirem per hour.
(d) A licensee shall establish radiation dose rate tri levels for the arveys required by Saragraphs (a) and (b)gger of this section. A licensee shall re uire t1at the individual performing the survey immediately notif the Radiation Safety Officer if a dose rate exceeds a trigger evel. (e) A licensee shall survey for removable contamination once each week all areas where radiopharmacauticals are routinely prep (ared for use.-administered, or stored.f) A licensee shall conduct t (e) of this section so as to be able to detect contamination on . each wipe sample of 2000 disintegrations per minute.
-(g) A licensee shall establish removable contamination trigger levels for the surveys required by paragraph (e) of this section.
< A licensee shall require that the individual performing the ~ survey immediately notify the Radiation Safety Officer if contamination exceeds the trigger level. (h)! A licensee shall retain a record of each-survey- for three years. The record must include the date of the survey, a )lan of
-each area surveyed. -the trigger level established for eac1 area, the detected dose rate at several ooints in each area expressed in millirem per hour or the removaale contamination in each area expressed in disintegrations per' minute per 100 square ; centimeters.c the instrument used to make the survey or analyze-i the samples, andithe initials of the-individual who perfonned the survey.
[51 FR 36951',-Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988] y . , - - y , ,m -
-,w-,m -
.. .y . - ,----- - ,
- . . . . _. . _ ~_ _ . -_. - _ _
C 0 i UNSEALED BYPRODUCT MATERIAL 36 August 11, 1997 HIGH DOSE WORKING DRAFT Section 35.75 Release of patient: Or human rescarch subject; sOntaining radiopharmaceutical: Or permanent imp' ants. (a) A 'icen ce may not authoriac release from confinement for medical carc any pa,tient,or human research subject administered a
,r mm e a 4. mms.
r, s . .m. . m .s . .mm. w.-mm + 4. m + 4. . m . 4. + ,s~ m .r . (1) The measured do 0 rate from the patient or the human resca ch subject is les; than 5 mil'irem; per hour at a distance of 1 meter, Or er+ 4. m. 4. + m 4m +sm m,+ m- +sm
<Os T.am 4.mm.+. m, . , ~ s. . mm. . e .m. , rmeme--s.
mi .. . msems 4m-+.
~ , ~ m m im . . ~ . .
is 'es; than 30 miq'icuric;rm . . (b) A licensee-ma medica' carc of any y=not patient authorize cr--human re' case rescarch subject from confinement for administered
<-m- +sm m,+4mm+ a permanent implant unti' the measured,
-m e m s --s ms4m <- dose
-- +sse rate c si vm wiiw m-vi
+sm smm, ,
viiw inuinui i wwwui wi v uvy w-+.w is iuvs .iiwii s millir^m:ywwiwiiwper hour at a distance of 1 meter. TCQ CD C170A hme O ijQA1 gus im vi r v 1 , www. w, a s s is Section 35.75 is revised to read as follows: Section 35.75 Release of individuals containing radiopharmaceuticals or permanent implants. (a) The licensee may authorize the release from its control of any individual who has been administered radiopharmaceuticals or permanent imp' ant; containing radioactive materia' if the total effective dose equivalent to-any other individual from exposure to the released individual is-not likely to exceed 5 millisieverts (0.5 rem).' (b) The licensee shall provide the released individual with instructions, including written-instructions, on actions recommended to maintain doses to other individuals as low as is
' Regulatory Guide 8.39 " Release of Patients Administered Radioactive Materials," describes-methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 millisieverts (0.5 rem).
L UNSEALED BYPRODUCT MATERIAL August 11, 1997 WORKING HIGH-DOSE DRAFT reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 millisievert (0.1 rem). If the dose to a breast-feeding infant or child could
- exceed- 1 millisievert-(0.1 rem) assuming- there were no interruption of breast-feeding, the instructions shall also include: -(1) guidance on the interruption or discontinuation of breast-feedin conseq)uences!g (c
1ffanyl of failure toand follow (2) The licensee shall maintain a record of the basis for information on the the guidancd'.' authorizing the release of an individual, for 3 years after the date of release, if the total effective dose equivalent is calculated by (1) using(the retained activity rather than the2) using a activity administered. 0.25 at 1 meter, (3) using the biological or effective half-life, : or (4) considering the shielding by tissue. (d) The licensee shall maintain a record, for 3 years after the date of release, that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem). Section 35.80 Technical requirements that apply to the provision of m bile nuclear medicine service. A licensee providing mobile nuclear medicine service shall: (a) Transport to each address of use only syringes or vials containing prepared radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of radiopharmaceutical kits: (b) Bring into each address of use all byproduct material to be usea .and, before leaving, remove all unused byproduct material and all associated waste: (c) Secure or keep under constant surveillance and immediate-control all byproduct material when in transit or at an address of use: (d) Check survey instruments and dose calibrators as described in Sections 35.50 -and 35.51, and check all other transported equipment for proper function before medical use at each address of use: (e) Carry a radiation detection survey meter in each vehicle that is being used to transport byproduct material, and, before _ - _ _ _ _ _ - _ _ _ _ _ _ _ _ _ . _ \
.s.
August 11, 1997 I- UNSEALED BYPRODUCT MATERIAL 38 WORKING HIGH DOSE DRAFT ,
- leaving a client address of.use, survey all radiopharmaceutical areas of use with a radiation detection survey meter to ensure that all-radiopharmaceuticals and all associated waste have been removed:-
- (f) Retain a record of'each survey required in paragrcph (e) of this section for three years. The record must include the date of the survey, a plan of each area that was surveyed, the measured dose rate at several points in each area of use expressed in millirem per hour, the instrument used to make the survey, and the initials of the individual who performed the-survey.
+
~ [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988].
e Section 35.90 Storage of volatiles and gases. A licensee shall store volatile radiopharmaceuticals and ' radioactive gases in the shipper's radiation shield and container. A licensee shali store a multi-dose container ~in a fume hood after drawing the first dosage from it. i L Section 35.92 Decay-in-storage. (a) A-licensee may hold byproduct material with a physical half-life of less than 65 days.for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of Section 20.2001- of this chapter if it:
-(1) Holds byproduct material for decay a minimum of ten half-lives; (2)' Monitors byproduct material at the container surface - before disposal as ordinary trash'and determines that its radioactivity cannot- be distinguished from the background radiation level:with a radiation detection survey meter set on
' its.most sensitive scale and with no interposed shielding: (3)-Removes or obliterates all radiation labels:- and with (4)all' Se parates and monitors each generator column indiv radiation shielding removed to ensure that it has 8
, .-,y- ac-.y-w.,, .---%,-y,- ee,- , ,, r w y-
UNSEALED BYPRODUCT MATERIAL 39 August 11, 1997 WORKING-HIGH DOSE-DRAFT ; decayed to background radiation level before disposal. (b) A licensee shall retain a recrrd of each dis >osal permitted under paragraph (a) of this section for tiree years. The record must include the date of the disposal, the date on which the byproduct material was placed in storage, the radionuclides disposed. the survey instrument used, the background dose rate, the dose rate measured at the surface of L each waste container, and the name of the individual who 4 performed the. disposal.- [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, - 2 1988: 56 FR 23472, May 21, 1991: 58 FR 67660, Dec. 22, 1993] 1 4 Subpart FD--Radiopharmaceuticals for Therapy
- Section 35.300 Use of unsealed byproduct material for therapeutic
' a dmi ni st rati onl(1 ncl udi ngVany Xdosagdst ofisodi Umil 6dide?I F131dn quantitles.greaterfthan;30 microcur:1es).
~A licensee may use for therapeutic administration any unscaled byproduct =teria' dosag'esMUsodiumliodidem131EinTquantities' greater:than 30fmifrocuriesso(any? unsealed
;f,0r/ therapeutic!administratioD 'prepafsd~fdr'ibypr6Juc medical Use"and~the is either:
(a) Obtained from a manufacturer or preparer licensed pursuant to 10- CFR 32.72 or equivalent Agreement- State requirements; or (b) Prepared by an authorized nuclear Sharmacist, a physician _ who is an authorized user and who meets.t1e requirements - specified -in:Section 35.920, or an individual under the supervision of either as specified in Section 35.25. l[59 FR 61784, Dec. 2, 1994]
- Section 35.310- Safety instruction.
(a) A licensee shall provide- radiation safety instruction for
- all personnel caring for-the patient or the human research subject receiving radiopharmaceutical thera >y and hospitalized
.for compliance with:Section 35.75 of this-c1 apter. To satisfy y-%-->r. ,,-,e-,.. m , , ,.w.-- --- . . ,_m,,-ew. v. , --.,s-- .- % ~
e ,,
. w LUNSEALED: BYPRODUCT MATER 1AL 40 August 11, 1997 HIGHLDOSE- WORKING DRAFT
, this requirement, the instruction must describe the licensee's procedures for: (-1) Patient or human research subject control: (2) Visitor control: (3)-Contamination control: (4) Waste control; and
-(5) Notification of the Radiation Safety.0fficer in case of the patient's or the human research subject's death or medical emergency.
(b) A. licensee shall keep for three years a list of ^ individuals receiving instruction required by paragraph (a) of this section, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction. [51 FR 36951. Oct. 16, 1986, as amended at 53 FR 19247. May 27, 1988: 59 FR 61784. Dec. 2, 1994) Section 35.315 Safety precautions. (a) For each patient or human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with , Section 35.75 of this chapter, a -licensee shall: , (1) Provide a private room with a private sanitary facility:
; (2) Post the patient's or the human research subject's door with a " Radioactive Materials" sign and note on the door or in the patient's or human-research subject's chart where and how-long visitors may stay in the patient's or the human research -
subject's room:
- (3) Authorize visits by-individuals under age 18 only on a case-by-case' basis with the approval of the authorized user after consultation with-the Radiation Safety Officer:
(4) Promptly after administration = of the dosage, measure the dose ~' rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance.
^ with the requirements of part 20 of this chapter. and retain for .
'three years a record of each survey that includes the time and-date of -the survey, .a plan of the area or list of points
l UNSEALED-BYPRODUCT MATERIAL 41 August 11, 1997 HIGH DOSE WORKING DRAFT surveyed, the measured dose rate at several aoints expressed in millirem per hour, the instrument used to mace the survey, and the initials of the individual.who made the survey. (5) Either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity cannot be distinguished from the natura,l background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed or handle them as radioactive waste. shieldinhr,ovidethe^atientorthehumanrccarchsubjectwith (6) radiation safety guidance that will hel^ to keep tohouseholdmcmbersand-thepublicasTowasrea:radiationdoce Onably achievable before authoriang relcacc of the patient or the human > rc carch subject. Bef_ ore authorizing:relsaseToffthefpatieht7or?hbmanifesearch subject,-provide that individual withLradiationisafety; guidance in~ accor' dance with: 635.75(b). (7) Survey the' patient's or the human research subject's room and private sanitary facility for_ removable contamination with a radiation detection survey instrument before assigning another 3atient or human research subject to the room, The room must not 3e reassigned until removable contamination is less than 200 disintegrations per minute per 100 square centimeters; and (8) Measure the thyroid burden of each individual who helped prepare or administer a dosage of iodine-131 within three days after administering the dosage, and retain for the period required by Section 20.1206(a) of this chapter a record of each thyroid burden measurement, its date, the name of the individual whose thyroid burden was measured, and the initials of the individual who made the measurements. (b) A licensec chall notify the Radiation Safety Officer i=cdiately if the patient or the human rc carch subject dies or has a medical emergency. Fl i censee fsh6Wnoti fy~f ths1R6di
~ ' ' '~ '~ ~
ati on~
'^ Safsti~? 0ffitEETa
~ ~~' s s;ooniasypassible!L '
( Ib_i f6the? pati 6.nt? oEth5?h.uman?
+ fes'5a r.chssubjebt[di
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lr UNSEALED BYPRODUCT MATERIAL 42 August-11, 1997 HIGH DOSE WORKING DRAFT PC1 CD Ofoti fb & ic inoc' se smanAnA s& CO ~ CD 100A7 usu 07 tE60."CE"6s%%44' o!l, 6f""iO57."EB"F5"c72cs" is', E' ','d54 "E6 G,m 6 5 m "Zi. ,,m%,,'m L : ".
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Section 35.320 Possession of survey instruments. A licensee-authorized to use byaroduct material for radio)harmaceutical therapy shall lave in its possession a porta)1e radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour, and a portable radiation measurement survey instrument ca)able of measuring dose rates over the range 1 millirem per 1our to 1000 millirem per hour. Subpart JE--Training and Experience Requirements Section 35.900 Radiation Safety Officer. Except as provided in Section 35.901, the licensee shall recuire an individual fulfilling the responsibilities of the Raciation Safety Officer as provided in-Section 35.32 to be an individual who: (a) Is certified (1) American by:f oHealth Physics in Comprehensive Health Board Physics: (2) American Board of Radiology; (3) American Board of Nuclear Medicine:
-(4) American Board of Science-in Nuclear Medicine:
(5) Board of Pharmaceutical Specialties in Nuclear Pharmacy: (6) American Board of Medical Physics in radiation oncology
. physics:
(7) Royal College of Physicians and Surgeons of Canada in
-nuclear medicine:
-(8):American Osteopathic Board of Radiology: or
-(9) American-Osteopathic Board of Nuclear Medicine; or (b) Has had classroom and laboratory training and experience as follows:
(1) 200 hours of classroom and laboratory training that includes: (i) Radiation physics and instrumentation:
.(ii) Radiation protection:
o UNSEALED BYPRODUCT MATERIAL 43 August 11. 1997 HIGH DOSE WORKING DRAFT (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiation biology; and (v) Radiopharmaceutical chemistry; and (2) One year of full time experience as a radiation safety technologist at a medical institution under the supervision of the individual identified as the Radiation Safety Officer on a Comission or Agreement State license that authorizes the medical use of byproduct material: or (c) Be an authorized user identified on the licensee's license. [51 FR 36951, Oct. 16, 1986, as amended at 59 FR 61786, Dec. 2, 1994] Section 35.901 Training for experienced Radiation Safety Officer. An individual identified as a Radiation Safety Officer on a Commission or Agreement State license before October 1.1986 need not comply with the training requirements of Section 35.900. Section 35.930 Training for therapeutic use of unsealed byproduct material (includingtdiagnostic studiesfinvolvingidosagesiofLsodium iodide I-131rin quantitiesigreaterithan!30lmicrocu_rjes}l. Except 30 provided in Section 35.970. the licen ce chall require the authorized user of radiopharmaceuticah in Section 35.300 to bc hysician who: (a) 1 certi ^"fied by: (1) The American Board of Llcar Medicine; (2) The ^=crican Board of Radiology in radiology, therapeutic or radution Oncolog ' radiology, (3) Nuc lear medicine by the k"cy:1 College of Physician: and Of Canada; or Sur^! con:
') The ^=crican 0;tcopathic Board of Radiology after 19B'; Or (b) Has had clascr00m and bboratory training in basic radichotopc handling techniques a therapeutic radio harm
^ Tows:aceuticah, and supervucd clinical pplicable to the u cxperience as fol (1) 80 hour Of ch; Groom and hboratory training that includes:
w UNSEALED BYPRODUCT MATERIAL 44- August 11.-1997
'HIGH DOSE WORKING DRAFT
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s i UNSEALED BYPRODUCT MATERIAL 45 August ll i 1997 HIGH DOSE WORKING DRAFT 1 ('i)l0rdering6receiVingKandisnpacking? radioactive materisis ~~ ~ t safely and performing lthe;relatedt radiation: surveys: ' (ii)-Calibrating dose calibrat6rstand: diagnostic instruments and performing'checksi for? proper 1 operation l of, survey 1 meters'.:
" (iii)iCalculating and; safe]y preparing patientLorthuman research: subject 1 dosages:' ~
~(iv)10 sing admini.strat1Ve? controls?to fp'reventierrorsfinf:the
~ ~ ~'
administration:of byproduct material:L (v) Using procedures to containtspilled byproductTmaterial ' safelyLand using proper;decontaminati.oniprolceduresy (3) The supervised: radiopharmaceuticalladministration experience, .under the supervision of an: authorized:useriat a medical. institution, shan: include: (1 ) f ora Fadmi ni st rati onii nS 10 ?i ndi vi dualslofii odi ne:131 Tor diagnostic studies'(involving dosagesLof: sodium iodide I-131'in quantities. greaterithan 30 microcuries)for for- treatment of ' hyperthyroidism oricardiac dysfunction:Torf l - . ( ii ) u Parenteral J admi ni strati on: i n L 3 Ei nd1 Vidual sibf! phosphorus-32 for treatment of myelo)roliferative.-disorders:or intracavitary: cancer: or strontium-8Forcsamarium-153 for~ treatment of bone metastasisH:xand; '
- (111 ) t orali admi ni st rati on si n s30:i ndi Vi dual s lofni odi net 1315 for
~' '
' ~
treatmentlofithyroidicarcinoma.L ~ Sectica-BE.932 Training for treatment of hyperthyroidism. Except as provided in Section 35.970, the licenscc chall require the authorized user of only iodinc 131 for the treatment of hyperthyroidism to be a oh"cician with ccial experience in thyroiddiscaccwhohashad'ciastroomand1 ^5boratory training in basic radici 0 tope handling techniques applicable to the use of iodinc 131 for <mtreating n ~, . hyperthyraidism, and supervised clinica'
~ nn - 4 n ~. n .
m i i w i i. ~ ivi iv~. (a) 80 hour of classroom and laboratory training that includes: (1) Radiation physics and instrumentation;
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e, e i UNSEALED-BYPRODUCT MATERIAL 47 August 11. 1997 1 HIGH DOSE WORKING DRAFT requj rement$i n135;930.( b(i i )3nd; 351930_(b(iiii N I Secti bF35i932sTrai ni ngif6 rya rentsraRadnii ni stratibniof l phosphorus -32Jfor ttreatmentiof f myel o )rol i ferati veldi sorders7br) intracavitaryicancerAor" strontium-83Kopsamarfum-1%for ~
.treatmentiof boneimetas.
t tasis 1 ExcEpt JasTprovi dedli n :Sscti oris35: 970 E the71 tsrisssTsh~al T
'Fequiresthe--authorizediuser"of only!parenteralJadministrati6h#6f phosphorus-32 forutreatmentiof'myeloaroliferativeedisorders:or" antracavitaryicancer nor; strontium-83 orisamarium-1533for^ -
treatment " of2 bone ' meta sta si s 0 to4 meet 9 the i requi rementii n 35 : 930 "^
'(b).Jexceptofor the1requirementsiind351930(b(1!)?and
~ ~' ~ ~ ~ ~ ' ~
35;930(b(iii.)i ~ ~ Sectiori 351933? Training?forioFaWadministratiorilofModine:131$for treatment . oft thyroid l carcinomab ExceptLas provided in?Sectionl35!970Mtheslicsnseefshall rec ui re - the ? autho'ri zed user <ofs only? oraltadmi ni strati on Tof" iocine-1311for;treatmentiofLthyroid/carcinomastolmeeththe re 35quirementTin135i930?(b)..
.930(b(i) Land: 354930(b(ii).~~ except%for^the5requirementsJin
~ ~ '~
~~
Section 35.970 Training for experienced authorized users. Physicians, dentists, or ^0 users for the medical. dentd, district; identified or podiatric use of as authorized byproduct material on a Commission or Agreement State license issued before A ril 1.1987 XX/XX/XX who perform only those methods of use for
. w1ich they were'authofized on that date need not comply with the training requirements of subpart J.
Section 35.971 Physician training in a three month program. 4-A physician who, before July 1. 1984, began a three month nuclear medicinc training program approved by the Accreditation
4 UNSEALED BYPRODUCT MATERIAL 48 August 11. 1997 HIGH DOSE WORKING DRAFT Ccuncil fcr Graduate Medical Educaticn and ha: succc sfully co ,pleted the ^regram need nct ccmply with the requirement: Of Secticn; 35.910 cr 35.920. (- Section 35.972 Recentness of training. The training and ex)erience specified in this subpart must have been obtained wit 1in the 7 years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed. [59 FR 61786, Dec. 2, 1994] Section 35.980 Training for an authorized nuclear pharmacist.
-The licensee shall require the authorized nuclear pharmacist to be a pharmacist who:
(a) Has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties, or (b)(1) Has completed 700 hours in a structured educational program consisting of both:
. (i) Didactic training in the following areas:
(A) Radiation physics and instrumentation: (B) Radiation protection: (C) Mathematics pertaining to the use and measurement of radioactivity: (D) Chemistry of byproduct material for medical use: and (E) Radiation biology; and (ii) Supervised experience in a nuclear pharmacy involving the following: (A) Shipping, receiving, and performing related radiation surveys: (B) Using and performing checks for proper operation of dose calibrators, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides; (C) Calculating. assaying, and safely preparing dosages for patients or human research subjects: (D) Using administrative controls to avoid mistakes in the administration of byproduct material:
-UNSEALED BYPRODUCT MATERIAL 49 August 11, 1997 HIGH; DOSE WORKING DRAFT (E) Using-procedures to prevent or minimize contamination and using)
(2 proper decontamination procedures: andHas3obtained receptor written certifi authorized nuclear pharmacist, that the above training 1as been
. satisfactorily completed and that the individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy.
[59 FR 61786, Dec. 2, 1994] Section 35.981 Training for experienced nuclear pharmacists, A licensee may apply for and must receive a license amendment identifying an experienced nuclear pharmacist as an authorized nuclear pharmacist before it allows this individual to work as an authorized nuclear pharmacist. A pharmacist who has completed a structured educational program as specified in Section 35.980(b)(1) before December 2,1994, and who is working in a nuclear pharmacy would qualify as an experienced nuclear pharmacist. An experienced nuclear pharmacist need not comply with the req)uirements on preceptor statement (Section35.980(b)(2 ) and qualify as an authorized nuclear pharmacist. [59 FR 61787, Dec. 2, 1994: 59 FR 65244, Dec. 19, 1994] SubpartKE--Enforcement Section 35.990 Violations. (a) The Commission may obtain an injunction or other court
-order to prevent a-violation of the provisions of--
(1) The-Atomic Energy Act of 1954, as amended: (2) Title II. of the Energy Reorganization Act of 1974, as amended: or (3) A regulation or order issued pursuant to those Acts. (b)-The Conmission may obtain a court order for the payment of a-civil penalty imposed under section 234 of the Atomic Energy Act: (1) For violations-of-- (i) Sections ~53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or
UNSEALED BYPRODUCT MATERIAL 50 August 11, 1997 HIGH DOSE WORKING DRAFT 109 offthe Atomic Energy Act of 1954, as amended:
-(ii) Section 206 of the Energy Reorganization Act: --
- (iii)- Any rule, regulation, or order issued pursuant to the sections specified;in paragraph (b)(1)(i) of this-section:
(iv) Any term, condition, or limitation of an under the sections specified in paragraph (1) (b)(1)y of this license issu section. ~ (2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended. [57 FR 55074. Nov. 24, 1992] Section 35.991 Criminal penalties. (a) Section 223 of the Atomic Energy Act of 1954, as amended. . provides for criminal sanctions for willful violation of. ' attempted violation of, or conspiracy to violate, any regulation issued under sections 161b.1611. or 161o of the Act. For
' purposes of section 223. all the regulations in part 35 are
- issued under one or more of sections 161b, 161i. or 1610. except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 35 that are not issued under subsections 161b. 1611, or 161o for the purposes of section 223 are as follows: Sections 35.1, 35.2, 35.7. 35.8. 35.12. 35.15, 35.18, 35.19, 35.57, 35.100. 35.600. 35.901, 35.970. 35.971,. 35.990. 35.991, and 35.999. [57 FR-55074. Nov. 24, 1992, as amended at 59 FR 61787. Dec. 2. 1994]- Section 35.999 Resolution of conflicting requirements during transition period. If the rules in this part conflict with the licensee's-radiation safety-program as-identified in its license - and-if that license was approved by the Commission before A)ril 1.1987-and has not been renewed since April 1.1987, then tie requirements in the license:will apply. However ifl that licensee-exercises its privilege to make minor changes in its radiation Esafety procedures that are not potentially important to safety under Section 35.31 of this chapter, the portion changed must-comply' with the requirements of this part. At the time of license
,h :., e UNSEALED BYPRODUCT MATERIAL 51 August 11. 1997 HIGH DOSE WORKING DRAFT renewal and thereafter, these amendments to this part shall apply.
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