ML20211A761
| ML20211A761 | |
| Person / Time | |
|---|---|
| Issue date: | 09/23/1997 |
| From: | Vacherlon P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| Shared Package | |
| ML20211A766 | List: |
| References | |
| REF-10CFR9.7 NACMUI, SECY-97-012-C, SECY-97-12-C, SECY-97-143-C, NUDOCS 9709240379 | |
| Download: ML20211A761 (40) | |
Text
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BRIEFING BOOK i
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ll Advisory Committee on the l
Medical Use of Isotopes i
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Fali 1997 Meeting on September 25 and 26,1997 t
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,, n,4 9709240379 970923 PDR ADVCM NACMUI FDR
Septembsr 23, 1997 MEMORANDUM TO: Document Control Desk FROM:
Patricia Vacherion
/s/
Medical and Academic Section Medical, Academ!c and Commercial Use Safety Branch 4
DATE:
September 22,1997
SUBJECT:
BRIEFING BOOK FOR THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES MEETING ON SEPTEMBER 25-26,1997 I am submitting a copy of the briefing book for the meeting of the Advisory Committee on the Madical Uses of isotopes on September 25-26,1997 Please place the briefing book into NUDOCS. The document is a public document. The briefing beak has been submitted to the Public Document Room.
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CONTACT: Patricia Vacherton 415-6376
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ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES t'~T AGENDA V
September 25 26,1997 TWO WHITE FLINT NORTH, T283 September 25.1997 8:00 am Ethics Refresher CLOSED Presenter: John Szabo, OGC 8:30 am introductions and Overview of Agenda Presenter: Larry Camper 8:45 am Director's Comments Presenter: Donald A. Cool 9.00 am Discussion of Previous ACMUI Recommendations Presenter: Larry Camper 9:15 am Discussion of Evaluation of Committee and Committee Membership Presenter: Larry Camper 10:00 am BREAK
(
10:15 am Update on the Revision of 10 CFR Part 35 Project and (3
'-)
Associated Activities Presenter: Cathy Haney 10:30 am 1979 Medical Policy Statement Presenter: Diane Flack 11:30am LUNCH 12:30 pm Discussion of the Requirements for a Quality Management Program Presenter: Sam Jones 2:30 pm BREAK 2:45 pm Discussion of the Requirements for a Radiation Safety Committee Presenter: Cathy Haney 5:00 pm Adjournment
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September 26,1997
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8:00 am -
Discussion of Requirements for Training and Experience 4
Presenter: Penny Lanzisera 10:00 am ~
BREAK i
10:15 am Continuation of the Discussion on the Requirements for Training and Experience 3
Presenter: Penny Lanzisera l
11:30 am LUNCH l
1 12:30 pm Discussion of Requirements for Notification of Patient and Related
[
Definition of Reportable Events l
Presenter: Marjorie Rothschild/ Cathy Haney i
l 2:15 pm BREAK i
f 2:30 pm Continuation of Discussion of Requirements for Notification of Patient and Related Definition of Reportable Events Presenter: Marjorie Rothschild/ Cathy Haney
(
4:15 pm Status Report on Rulemaking and Guidance Presenter Cathy Haney Topics:
Part 33 Rulemaking Carbon-14 Petition for Rulemaking University of Cincinnati Petition on 10 CFR 20,1301 Radiopharmacy Guidance 5:00 pm Adjournment O
d 1
i 47070 Federal Register / Vol. 62 No.172 / Friday, September 5,1997 / Notices For the U.S. Nuclear Regulatory 11545 Rockville Pike, Room T2B3, approved collection of information d
Commission.
Rockville, MD 20852-273a.
entitled Subchapter C of Chapter I, Title John W.N. mckey, FOR FURTHER INFORMATION CONTACT:
35 Code of i ederal Regulations, OMB Chief, Low Level Woste and Decommissioning Diane Flack, U.S. Nuclear Regulatory No. 3207-0001. In accordance with sec.
Projects Branch. Dwision of Wast' Commission, Office of Nuclear Material 3506(c)(2)(A)of tem Paperwork Managernent. Office of Nucleor Morenal Safetyand Safeguards Safety and Safeguards, MS TBF5, Reduction Act of1995 PCC published Washington, DC 20555, Telephone (301) a notice in the Federal Register (62 FR IFR Doc, 97-23597 Filed 9-4-97: 8'45 aml 415-5681, 29165, May 29,19961 requesting e4WNo coor 7se64M comment on this proposed collection.
Conduct of the Meetin8 The comment period ended July 28 I
NUCLEAR REGULATORY Judith Ann Stitt, M.D., will chair the 1997. PCC received no comments in COMMISSION meeting. Dr. Stitt will conduct the response to that notice.
rueeting in a manner that will facilitate DATES: Written comments on this Advisory Committee on the Medical the orderly conduct of business. The proposed action regasding the collection Uses of lootopes: Meeting Notice I 11 Win 8 Procedures apply to public of information must be submitted by i
participation la the meeting:
October 6,1997, AGENCY: U.S. Nuclear P.egulatory
- 1. Persons who wish to provide a ApoREssEs: Address all comments Commission, written statement should submit a concerning this notice to Edward 11.
ACTION: Notice of meeting.
reproducible copy to Diane Flack Clarke, Desk Officer for Panama Canal (address listed previously), by Commission. Office of informauon and
SUMMARY
- The U.S. Nuclear Regulatory September 18,1997, Statements must Regulatory Affairs, Room 3228 New Commission will convene a meedng of pertain to the topics on the agenda for Executive Office Building, Office of the Advisory Committee on the Medical the meeting. -
Management and Budget, Washington, Uses of Isotopes ( ACMUll on September
- 2. At the meeting, questions from D.C. 20503.
25-26,1997 The meeting will take members of the public will be permitted FOR FURTHER INFORMATION CONTACT: For place at the address provided below, All at the discretion of the Chairman, a complete copy of the collection of sessions of the meeting will be open to
- 3. The transcript and written information or related information, the public, except where specifically comments will be available for noted otherwise.
contact Ruthlluff, Office of the inspection, and copying, for a fee, at the Secretary, Panama Canal Commission, Topics of discussion will include: (1)
NRC Public Document Room,2120 L 202-634-6441, An evaluation of the ACMUI and the Street, N.W., Lower Level, Washington, SUPPLEMENTARY INFORMATION: Under the composition of its membership: (2) an DC 20555, telephone (202) 634-3273, on update on the revision of to CFR part or about October 3,1997. Minutes of the Paperwork Reduction Act of1995 (44 3
35 and associated activities:(3) a neeting will be available on or about U.S.C. 3501 ci seq.), Federal agencies must obtain approval from the Office of discussion of the re.guirements for (a) a November 14,1997.
Quality Management Program,(b) a
- 4. Seating for the public will be on a Management and Budget (OMB) for each radiation safety committee. (c) training first-come, first served basis, collection of information they conduct or sponsor. Collection of information is and experience, and (d) notification of This meeting will be held in defined in 44 U.S C,3502(3)and 5 CFR patients: (4) a discussion of possible accordance with the Atomic Energy Act 1320.3(c). Section 3507(a)(1)(D) of the opuons for revising the 1979 Medical of 1954, as amended (primarily Section Paperwork Reduction Act of 1995 Policy Statement; and (5) a discussion of 161a); the Federal Advisory Committee requires Federal agencies to provide a previous ACMUI recommendations.
Act (5 U.S.C. App): and the Additionally, the staff will provide an Commission's regulations in Title to, notice in the Federal Register stating that the agency has made such update on several rulemakings and U.S. Code of Federal Regulations, part 7.
submission and setting forth the regulatory guides: (1) Rulemaking for Dated: August 29.1997.
foilowing information:
part 33. " Specific Domestic Licenses of Kenneth R. Hart.
Title:
Subchapter C (Shipping ard Brosd Scope for Byproduct Material.
(2) petition for rulemaking for carbon 14 Acting Secretaryof the Commission.
Navigation) of Chapter 1,35 CFR.
use; (3) petition from the University of (FR Doc. 97-23610 Filed 9-4-97, a 45 ami gg Canal Treaty of 1977 and section 1101 Cincinnati regarding 10 CFR 20.1301, e4WNo Coot M9&cM and (4) radiopharmacy guidance.
ofits implementing legislation. Pub. L 96-70, as amended, vests in the Panama In addition, on September 25,1997, from 8.00 a.m. to 8:30 a.m., there will PANAMA CANAL COMMISSION Canal Commission the responsibility be a closed session of the ACMUI to and authority to maintain and operate discuss ethics rules and their submission for OMB Review; the Panama Canal. Section 1801 of Pub.
application. This session will be closed Comment Reyuest L. 96-70, codified at 22 U.S.C. 3811.
on the grounds that the meeting will explicitly authorizes the Commis=lon to AGENCY: Panama Canal Commission.
promulgate regulations governing relate solely to internal personnel rules ACTION: Notice, navigation of the waters of the Panama
.md/or practices of the agency and will involve information the disclosure of Canal. The information, required by
SUMMARY
- In accordance with the varicus sections of Subchapter C which would constitute a clearly requirements of the Paperwork (Shipping and Navigation) of Title 35 of unwarranted invasion of personal Reduction Act of 1995 (Pub. L 104-13 the Code of Federal Regulations, and privacy.
109 Stat.163), the Panama Canal obtained through the use of the subject DATES:The meeting will begin at 8:30 Commission (PCC) hereby gives notice it forms, is essential for the Commission to a.m., on September 25,1997, and 8:00 has submitted to the Office of carry out its mission in a safe and kj a.m. on September 26.1997.
Management and Budget for approval of efficient manner.
ADDRES$ES: U.S. Nuclear Regulatory a Paperwork Reduction Act Submission Needs and Uses: On December 24, Commission, Two White Flint North, (83-1) for a revision of a currently 1981, OMB approved a collection of
UNITED STATES NUCLEAR REGULATORY COMMISSION RULES and REGULATIONS TITLE 10 CHAPTER 1. CODE OF FEDERAL REGULATIONS-ENERGY O)
Ls-PART MEDICAL USE OF BYPRODUCT MATERIAL m.or,
-o.-e inf.-.n Su.p.,1c-o
- 1ec, p,,.,mece_.,,
Requirements Therapy Sec.
Possession, use.
35 300 Use of unsealed byproduct material of dose calibrators.pation, and check 35.1 Pu pose and scope.
35.50 for therapeutic admimstration 35.2 Defmitions.
35 5 Maintenance of records.
35 51 Calibration snd check of survey 35.310 Safety matructiori 356 Provisions for research involving instruments, 35 315 Safety precautic is.
human subjects.
35 52 Possession, use. cahbrstion. and 35.320 Possession of survey instruments 357 FDA.other Federal. and State check of instruments to measure Subput G-Souren f.r Deppy requirements.
dosages of alpha.or beta emitting 35.8 information collection requirements:
radionuchdes 35 46J Use of sources for brachytherap)
OMB approval.
3553 Measurement of dosages of unsealed 35404 Release of patients or human 35.11 Ocense required.
byproduct material for medical use research subjects treated with 35.12 Application for license. amendment.
35.57 Authoritation for cahbration and temporsty implanta or renewal reference sources.
35.400 Brachytherapy sources inventory 35.13 Ucense amendments.
35 59 Requirements for possession of sealed 35 410 Safety mstruction.
3514 Notifications.
sources and brachytherapy sources.
35 415 Safety precautions 3115 Exemptions regardingType A 35 00 Synnge shields and labels.
35 420 Possession of survey instrument specific hcenses of broad scope.
35 61 Vial shields and labels.
Subpart H-Sealed S.urces for D6egnoels 35.18 Ucense issuance.
35.70 Surveys for cantammation and 35.19 Snecific exemptions.
ambient radiacon exposure ratt.
35 500 Use of sealed sources for diagnosis
)> 3535 Release of individuals contaimns 35 520 Availabihty of survey metrument p}
Subpert B--Genero, Administraeve radiopharmaceuccals or permanent Subpart WTotemwapy 5(.G' Requkomente unplants.
35.20 ALARA program.
35.80 Technical rsquirements that apply 15.000 Use of a sealed source in a 35.21 Radiation Safety Officer.
to the provision of mobile nuclear teletherapy umt.
35.22 Radiation Safety Committee.
medicme service.
35.e05 Maintenance and repair restnctions.
35.23 Statements of authonty and 35.90 Storage of volatiles and gases.
35.006 Ucense amendments.
responsibihties.
35 92 Decay in. storage.
35.610 Safety instruction.
35.25 Supervision.
35615 Safety precautions.
35.620 Possession of survey instrument.
35.29 Admmistrative requirements thet Subpert Ng % and Eam 35.630 Dosimetry equipment.
apply to the provision of mobile nuclear 31100 Use of unsealed byproduct material 35.832 Full calibration measurements.
medictne service.
br uptake, dilution and excretion 35.634 Penodic spot. checks.
35.31 Radiation safety program ctianees.
studies 35 636 Safety checks for taletherapy 35 33 Quahty management program, 35 33 NotiAcations. reports and records 35.120 Posseesion of survey instrument.
facilities.
35.641 distion surveys for teletherapy Subpart E
-;, and 8 aa m==as,
3149 S ie lo e led sources or 31200 Use of unsealed byproduct ma.erial devices br medical use.
35.643 Modification of teletherap, unit or r imaging and locahzation studies ~
room before besmning a treatment 35.204 Permissible molybdenum-se c ncentration.
35.645 Reports of teletherapy surveys.
35.205 Controlof aerosols and gases.
Ms.
d mures.
35.220 Possession of survey matruments.
35.647 Five-year inspection.
sm %
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1 V
q 35 1 January 31,1997
35.2 PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL Sut9ert J-TraWag and Esperience f-Requiremente l
Subpart A--GeneralInformation Authority: Secs 81.161.182.183.68 Stat 35 900 Radiation Safety Ofhcer h935.948953,954. as amended (42 L' S C i 35.1 Purpose and scope.
35 901 Tra ing for empenenced Radiation i, 2111,2201,2232. 2233L sec. 201,88 Stat This part prescnbes te utrements and Tfaming for uptake. ddution. and E
Provisions for the medica use of 35 910 escretion studies E
byproduct material and for issuance of 35 920 Traming for imaging and locahsation l specific licenses authorizing the medical studies L
use of this matenal.These requirements 15930 Trainms for therapeutic use of and provisions provide for the unsealed hvproduct matenal protection of the public health and 35 932 Tramma for treatment of safety. The requirements and provisions 6his part are in addition to, and not in 35 9 Training o treatment of thyroid substitution for, others in this chapter.
caremome The requirements and provisions of 35 940 Tramma for use of brachytherapy Parts 19,20,21,30,71, and 170 of this sources 35 941 Tramma for ophthalmic use of Ch8pter apply to applicants and licer& subject to this part unless strontium-90.
e 35 950 Tramms for use
- sealed sources for sps 'q y exempted.
F diagrosis.
35 9eo Tramma for te etherapy I 35.2 N 35 961 Trammg for teistherapy physicist.
35 9'O Tramma for exp nenced authonted
" Address of use" means the buildmg or buildings that are identified on the users 35 971 Physician trainmg m a three month p license and where byproduct material may be received. used, or stored.
359 2 Recentness of trainmg g " Agreement State" means any State 15 980 Trainmg for an authorized nuclear
- with which the Commission or the phar mac ut Atomic Energy Commission has entered n 981 Tramma fo expenenced nuclear into an effective agreement under pharmac nts subsection 274b of the Atomic Energy Act of 1354, as amended.
Sut9 art K-Enforcement "ALARA" (as low as reasonably 35 990 Wolations achievable) means makmg every 35 991 Cnminal penalties reasonable effort to maintain exposures 35 W9 Resolution of confhrting to taotation as far below the dose limits requirements during tra nution period as is practical:
(1) Consistent with the purpose for which the licensed actmty is undertaken.
(2) Taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and (3)In relation to utilitation 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 stonng byproduct material O
September 29,1995 35-2
35.2 35.2 PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL 4
y Authorised nuclear pharmacist means Diagnoetic clinico!proceduree l
a pharmacist who is:
manualmeans a collection of written (1) Board certified as a nuclear procedures that desalbes each method pharmaclet by the Board of I (and other instructions and precautione)
Pharmwat Specialties; by which the licensee performe (2) Identified as an authorized nuclear f diagnostic clinical procedures; where pharmacist on a Commission or each diagnostic clinical procedure hae w
Agreement State license that authorizes R been approved by the authorised user
^
the use of byproduct materialin the and includes the radiopharmaceutical, practice of nuclear pharmacy; or dosage, and route of administration.
(3) Identified as an authorized nuclear 1
~
pi armacist on a permit issued by a
&===laalon or Agreement State specific sR licensee of broad scope that le r-ra authorized to permit the use of I
" Management"means the chief E byproduct materialin the practice of g executive of5cer or that person's 3 nuclear pharmacy.
g delegate or delegates.
4 "MedicalInstitution" mean an Authorized user means a physician, e
dentist. or atrist who is:
5 organization in which seversi medical (t) certified by at leas' one of a disciplines are practiced.
the boards listed in Paragraph (a) of L
$$ 35.9t 0, 35.920,35.930, 35.940, 35.950, or 35.960; (2) Identified as an authorized user on a Commission or Agreement State r-license that authorizes the medical use l Medical use means the intentional of byproduct material; or 0; internal or external aciministration of (3) Identified as an authorized user on $ byproduct material or the radiation a permit issued by a Commission or e therefrom to patients or human research 4
Agnement State specific licensee of
"; subjects under the supervision of an broad ecope that is authorized to permit
- authorized user, the medical use of byproduct material. L i!Od-
"Brechytherapy source" means an
" Ministerial change" means a change individual sealed source or a that le made, after ascertaining the manufacturer-maa== bled source train g applicable requirements, by persons in that is not designed to be disaaeembled g authority in conformance with the by the user, e requirements and without mairing a
" Dedicated check oource" mes is a t discretionary judgment about whether radioactive source that is used to assure
- those requiremente should apply in the the constant operation of a radiation case at hand.
l detection or measurement device over g several months or years, Dental use" means the intentional g "temal administration of the radiation ex g
i from byproduct material to human a beinse in the practice of dentistry in accordance with a license leeued by a State or Territory of the United States, the District of Columbia, or the i
Commonwealth of Puerto Rico.
" Dentist" maana an individual i
licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry.
E M
i
35,2 35.2 PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL histisodministration means the (5) A brachytherapy radiation dose;
" Mobile nuclear medicine service" administration of; (i) Involving the wrong individual, means the transportation and medical (1) A radiopharmaceutical dosage wrong radioisotope, or wrong treatment M use of byproduct matenal.
greater than 30 microcuries of either site (escluding, for permanent implants,
% " Output" means the exposure rate.
sodium iodide 1-125 or 1-131:
seeds that were implanted in the correct a dose rate, or a quantity related in a h "letherapy unit for a specified set of
- I" (i) Involvin8 the wron8 individual or site);
te wrong radiopharmaceutical; or
( ) nvolving a sealed source that is exposure conditions tit) When both the administered leaking.
dosage differs from the prescribed (iii) When, for a temporary implant, J
dosage by more than 20 percent of the one or more sealed sources are not l
presenbed dosage and the difference removed upon completion of the Phortnacast means an individual between the administered dosage and procedure: or y hcensed by a State or Territory of the iv When the calculated admmistered u United States,the District of Columbia.
j presenbed dosage exceeds 30 g
(se) differs from the presenbed dose by E or the Commonwealth of Puerto Rico to microcunes.
e do (2) A therapeutic radiopharmaceutical E more than 20 percent of the presenbed
- practice pharmacy, dose.
dosage, other than sodium iodide I-125 E
(6) A diagnostic radiopharmaceutical b
or 1-131:
dosage, other than quantities greater (i) Involving the wrer8 individual
toute of admmistration; or (i) Involving the w rong mdividual,
,'Ph sician" means a medical doctor I
h (ii) When the administered dosage wrong radiopharmaceutical, wrong nr doctor of steopathy hcensed by a
$ differs from the presenbed dosage by route of administration, or when the g more than 20 percent of the presenbed admmistered dosage differs from the t i Colu a
3 osage.
prescribed dosage; and Commonwealth of Puerto Rico to (3) A gamma stereotactic radiosurgery (ii) When the dose to the individual presenbe drugs in the practice of radiation dose.
esceeds 5 rems effective dose medicine.
equivalent or 50 rems dose equivalent
..Podiatnc use" means the intentional (i) Involving the w rong individual or any individual organ.
external administration of the radiation wrong treatment site; or m from byproduct matenal to human lii) When the calculated total administered dose differs from the total g beings in the practice of podiatry in E accordance with a heense issued by a prescribed dose by more than to percent
- State or Terntory of the United States, of the total prescnbed dose.
the Distnct of Columbia, or the (4) A teletherapy radiatior, dose.
Commonwealth of Puerto Rico.
(i) Involving the wrong individual-
"Podiatnst" means an individual wrong mode of treatment, or wrong licensed by a State or Terntory of the treatment site; United States, the Distnct of Columbia, (ii) When the treatment consists of or the Commonwealth of Puerto Rico to three or fewer fractions and the practice podiatry, calculated total administered dose differs from the total presenbed dose by more than 10 percent of the total presenbed dose; (iii) When the calculated weekly administered dose exceeds the weekly prescribed dose by 30 percent or more of the weekly prescnbed dose; or (iv) When the calculated total cdministered dose differs from the total prescribed dose by more than 20 percent of the total presenbed dose.
O September 29,1995 35-4
35.2-35.2 PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL i.
Prescribed dosage means *be quantity Recordoble event means the lYntten directive means an order in of radiopharmaceutical activity as admmistration of:
writing for a specific patient or human documented:
(1) A radiopharmaceut: cal or research subject. dated and signed by an (1)In a written directive, or -
radiation without a wntten directive authorized user prior to the (2) Either in the diagnostic clmical where a wntten directive is required; administration of a radiopharmaceutical i
i procedures manual or m any (2) A radiopharmaceutical or or radiation, except as specified in appropnate record in accordance with radiation where a wntten directive is paragraph (6) of this definition, i
the directions of the authonzed user for required without dady recordmg of each containing the following information:
g diagnostic procedures administered radiopharmaceutical (1) For any administration of g. Prescrsbeddose means dosage or radiation dose in the quantities greater than 30 microcuries of (1) For gamma stereotactic appropriate record; either sodium iodide 1-125 or 1 131: the
- radiosurgery, the total dose as (3) A radiopharmaceutical dosage dosage; o documented in the wntten directive; greater than 30 microcunes of either (2) For a therapeutic admmistration of s
j-(2) For teletherapy, the total dose and ;o sodium iodide I-125 or 1-131 when both:
a radiopharmaceutical other than j
dose per fraction as documented in the G (i) The admmistered dosage differs.
sodium iodide I-125 or 1-131: the wnt.en directive; or E from the presenbed dosage by more radiopharmaceutical, dosage, and route (3) For brachytherapy, either the total j
of administration; source strength and exposure time or the $ than 10 percent of the presenbed s
dosage, and E (3) For samma stereotactic total dose, as documented in the written (ii) The difference between the
- radiosurgery: target coordinates, directive.
collimator size, plus pattern, and total administered dosage and presenbed a
i dosage exceeds 15 microcunes:
$ dose; l
(4) A therapeutic radiopharmaceutical (4) For teletherapy: the total dose, dosage, other than sodium iodide 1-125 dose per !* action. treatment site, and 2
or 1-131. when the administered dosage overall treatment penod, differs from the prescribed dosage by (5) For high. dose rate remote
- nore than 10 percent of the prescribed afterloading brachytherapy:. the E " Radiation Safety Officer" means the
- dosage, radioisotope, treatment site, and total i
$ individualidentified as the Radiation (5) A teletherapy radiation dose when dose; or m Safety Officer on a Commission license.
the calculated weekly administered (6) For all other brachytherapy:
2
. dose exceeds the w eekly prescribed (t) Prior to implantation: the dose by 15 percent or more of the
- r. dioisotope, number of sources, and weekly prescribed dose: or source strengths; and I
(61 A brachytherapy radiation dose (ii) After implantation but prior to I
when the calculated administered dose completion of the procedure: the I
differs from the presenbed dose by more radioisotope, treatment site, and total than 10 percent of the prescribed dose.
source strength and exposure time (or, equivalently, the total dose) l l
1 i
Sealed source" means any byproduct i
material that is encased in a capsule 4 designed to prevent leakage or escape of
$ the byproduct matenal.
" Teletherapy physicist" means the e
i
! individualidentified as the teletherapy l
physicist on a Commission license.
i
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i l
1 i
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1 35 5 September 29,1995 1
35,ll(c) 35.5 PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL i 35.5 ademienance of receros.
I 35.s Intormation conection
$ 35.11 ucense required.
- "'******8***I' (a) A person shall not manufacture.
Each record required by this part must (a)The Commission has submitted the g produce. acquire, receive,, possess, use, belebible throughout the retention information collection requirements
- or transfer byproduct material for period specified by each Commission g contained in this part to the Office of
- med' cal use except in accordance with reFulation. m reconi may be the g Management and Budget (OMB) for 5 a specific license issued by the oriF nal or a reproduced copy or a approval as required by the Paperwork $ Commission or an Agreement State, or i
e microform provided that the copy or b Reduction Act of 1980 (44 U.S C. 3501 et as allowed in paragraph (b) or (c) of this microform is authenticated by
- seq.). OMB has approved the section.
authorized personnel and that the information collection requirements in
% microform is capable of producing a this part under control number 31W
@ cleir copy throughout the required 001a e retention period.The record may also be
' st red in electronic rnedia with the (b) Anindividualmay receive, E capability for producing leF ble, 4 Possess, use, or transfer byproduct i
accur;te, and complete records dunng 8 regulations in this chapter under the e materialin scardance with the the required retention period. Records
>(b) The appros ed information such cs letters, drawings, specifications, collection requirements contained in w supervision of an :.uthe,nzed user as must include all pertinent infonnation this Part appear in $$ 35.6,35.12,35.13. E provided in i 35.25. unless prohibited by such ts stamps, initials, and signatures, 35.14,35.20,35.21,35.22,35.23,35.29, license condition.
The hcensee shall maintain adequate
$ 35,13, 35.50, 35.51, 35.5 2, 35.53, 35.59, safeguards against tampenng with and
- 35.60,35.61,35,70,35.75,35.80,35.92, loss of records w 35.204, 35.205, 35.310, 35.315, 35. 404, 3 35.406,35.410,35.415,35.606,35.610,
~
35.615,35.630,35.632,35.634,35.636, (c) An individual may prepare 9 35.6 Provisions for research involvin9 35.641,35.643,35.645,35.647,35.980,- unsealed byproduct material for medical human subjects.
and 35.98L U use in accordance with the regulations
- in this chapter under the supervision of A licensee may conduct research 5 an authorized nuclear pharmacist or involving human subjects using S authorized user as provided in 5 35.25, byproduct material provided that the unless prohibited by license condition.
~
research is conducted, funded, (c) This part contains information supported, or regulated by another collection requirements in addition to Federal Agency which has implemented those approv-d under the control tha Federal Policy for the Protection of Human Subjects. Otherwise, a licensee
, number specified in paragraph (a) of this shall apply for and receive approval of g section.These information collection g requirements and the control numbers a speci6c amendment to its NRC license E under which they are approved as betore conducting such research. Both I0ll0W8:
types oflimnsees shall, at a minimum, g
(1)In 5 35.12 Form NRC-313 is 4
e obtain informed consent from the approved under control number 3150-
& human sub}ects and obtain prior review 0120.
g and approval of the research activities e by an " institutional Review Board"in accordan with the meaning of these terms as defined and described in the
{ (d) OMB has assigned control number Federal Policy for the Protection of Human Subjects, p; 3150-0171 for the information collection E requirements contained in il 35.32 and 5 35.33.
I 35.7 FDA, other Fed aral, and State requiremmte.
N; thing in this part relieves the licensee from complying with (pplicable FDA, other Federal, and State requirements governing radioactive drugs or devices.
O 05-6 January 31,1997
35.12(c) 35.15(d)
PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL Q
( 35.12 Appooemen ter meenee.
9 35.13 usenesamenemoma.
6 35.14 Noenospens.
A licensee shall apply for and must (a) A licensee shall provide to the (allf the application is for medical use 3 receive a license amendment:
Comminion a copy of the board sited in a medical institution, only the
- 1 (a) Before it receives or uses certification, the Commission or institution's management may apply. lf e byproduct material for a clinical Agreement State license, or the permit the application is for medical use not
- / procedure permitted under this Part but issued by a licensee of broad scope for
)
sited in a medicalinstitution. any person not permitted by the license issued each individual tw later than 30 days may apply, pursuant to this part; after the date that the licensee permits (b) An application for a license for the individual to work as an authorized medical use of byproduct matenal as user or an authorized nuclear
~
described in iI 35.100.35.200, 35.300.
pharmacist pursuant to $ 35.13 (b)(1) 35.400, and 35.500 of this art must be (b) Before it permits anyone to work through (b)(4).
made by filing an origina and one copy as an authorized user or authorized (b) A licensee shall notify the nuclear pharmacist under the license, Comminion by letter no later than 30 a al n " or d nee in except an individual who is:
days after.
compieting the form, refer to the (1) An authodzed user certified by the (1) An authorized user, an authorized R instructions in the most current versions organizations specified in paragraph (a) nuclear pharmacist. Radiation Safety
{ of the appropriate Regulatory Guides. A of $ 35.910. 35.920,35.930,35.940, Officer, or teletherop physicist e request for a license amendment or 35.950, or 35.960-Permanently discon ues performance
- renewal may be submitted as an onginal (2) An authoriz'ed nuclear pharmacist [o of duties under the lice..;e or has a and one copy in letter format.
certified by the organization specified in 3 name change; or
. Paragraph (a) of 5 35.980; E (2) The licensee's mailing address m dc use f roduc at al as (3' *"*I * " * * " "
"**' ' E " (*")I* licensee shall mail the desenbed in i 35.000 of this P'rt must be.5 an authonzed nuclear pharmacist on a c The made by filing an onginal and one copy e Commission or Agreement State license documents required in this section to of Form NRC-313. For guidance in
- that authonzes the use of byproduct the approhriste address identified in materialin medical use or in the
$ 30.6 of is chapter.
inst ctio e n the m'ost c ent version Practice of nuclear pharmacy, of the appropnate Regulatory Guide. A request for a license amendment or "hentifIe as an authorized user or renev al may be submitted as an onginal an authorind nuclear pharmacist on a 3 36.15 Esempeone regereng Type A Permit issued by a Commission or speconc Noeness et brose scope.
O (d
tcop of eg ao guides' Agreement State specific licensee of A licensee possessing a Type A t
j application forms or to submit an broad scope that is authonzed to permit specific license of broad scope for D
application or en amendment request-the use of byproduct material in medical medical use is exempt from the refer to 130.6 of this chapter.
use or in the practice of nuclear following:
P armacy.respectively.
(a) The provisions of $ 35.13(b);
h (b) The prodstons of $ 35.13(e) regarding additions to or changes in the arcas of use only at the addresses 3 (e) An applicant that satisfies the (c) Before it changes Radiation Safety sp(ecified in the license:c)The provisio D requirements speci6ed in 10 CFR.33.13 Officers or Teletherapy Physicista:
g y o,
- YPe A specinc hcense (d) Before it ordere byproduct material (d)The provisions of $ 35.14(b)(1) for Ey scope.
g in exceu of the amount or radionuclide an authorized user or an authorized g
{
g or form different than authorized on the nuclear pharmacist.
license; and g
3 are(e) Before it adds to or changes the as of use or address or addrenes of use identified in the application or on the license.
35 7 September 29,1995
l 35.21(b) 35.1g PART 35 o MEDICAL USE OF BYPf1000CT MATERIAL lmis usemeteousnos Subpert B-Oeneral Administrruve i 36.21 m setery omoor.
~
ne Commission shallissue a license Moguiremente (a) A licensee shall appoint a Radiation Safety Officer responsible for for the medical use of byproduct I
' m troplementing the radiation safety material for a term of five years if:
(a) Each licensee shall develop and program.The licensee, through the (a)The applicant has filed Form NRC-implement a written radiation protection Radiation Safety Officer, shall ensure 313 " Application for Materials IJcense" cgram est includes provisions for that radiation safety activities are being
{eeP ng doses ALARA.
performed in accordance with approved in accordance with the instructions in i
l 35')12:(b ne a plicant paragraph (a) of this section-in the daily operation of the licensee's (b) To satisfy the mquimment of procedurse and regulatory requirements applicable fee as pro.sas paid any vided in Part 170 of (1) At a medicalinstitution, byproduct material prograrn.
this chapter management, the Radiation Safety (b) ne Radiation Safety Officer shall:
(c) The Commission finds the Officer, and all sudortsed users must (1) Investigate overexposures, applicant equipped and committed to P*'t2ci *te in the program as requested accidents, spills, losses, thefts, P
observe the safety standards established by the Commission in this
~ try the Radiation Safety t'a==ittee.
unauthorssed receipts, uses, transfers, (2) For licensees that are not medical disposala, misadministrations, and other Chapter for the protection of the public 3a lastitutions, management and all deviations from approved radiation St health and safety; and 5 authorised users must participate in the safety practice and implement h req (d)ne applicant meets the uirements of Part 30 of this chapter, 3 Program as requested by the Radiation corrective actions as necessary; Safety Officer.
(2) Establish, collect in one binder or i
E l as.te speceme esempeone.
(c) ne program must include notice to file, and implement wntten policy and The Commission may, upon workers of the program's existence and procedures for, application of any interested person or workers' responsibility to help keep (i) Authonzing the purchase cf upon its own initiative, grant such dose equivalents ALARA, a review of
@ byproduct material; exemptions from the regulations in this summaries of the types and amounts of 8 (ii) Receiving and opening packages of part as it determines are authorized by byproduct material used, occupational e byproduct material; law and will not endanger life or doses, changes in radiation safety 1
(iii) Stonna byproduct materiah property or the common defense and,
procedures and safety measures, and (iv) Keeping an inventory record of secunty and are othe wise in the pubhc continuing education and training for all byproduct materiah interest. The Commission w 11 review personnel who work with or in the (v) Using byproduct material safely:
requests for exemptions from training vicinity of byproduct nuterial The (vil Taking emergency action if and exprience requirements with the purpose of the review is to ensure that control of byproduct materialis lost; assistance ofits Advisory Committee on licensees make a reasonable effort to (vii) performing periodic radiation the Medical Uses of lootopes.
maintain individual and collective surveys; occupationaldoses ALARA.
(viii) Performing checks of survey instruments and other safety equipment:
(ix) Disposing of byproduct materish (x) Training personnel who work in or frequent areas where byproduct materialis used or stored:
(xi) Keeping a copy of all records and reports required by the Commission regulations, a copy of these regulations, a copy of each licensing request and license and amendments, and the wntten policy and procedures requirsd by the regulations.
(3) Brief management cace each year on the byproduct material program:
(4) Establish personnel exposure investigational levels that, when exceeded, will initiate an investigation.
by the Radiation Safety Officer of the cause of the wxposure:
O September 29,1995 35-8
PART 35 o W. DICAL UN OF BYPRODUCT MATERIAL (5) Establish penonnel exposure (2)(i) Review, on the basis of safety 6 36J3 testemente of auenerity and investigational levels that, when and with regard to the training and r"T"""*'"""
eaceeded, will initiate a prompt experiena standarde in Subpart J of this (a) A licensee abau provide the investigation by the Radiation Safety
, and approve or disapprove any Radiation Safety Otheer, and at a Omcor of the cause of the esposure and dividual who is to be timed as an seencal institution the Renaten Safety a cons 6deration of actions that might be autho,ised user, an authorised nuclear Comecas, samoient authority, taken to reduce the probability of pharmacist, the Radiation Safety OfAcer.
organisational fraedom, and recurrence; t; or a teletherapy physicist before management rerogative, to:
(el For medical me not at a medical
& submitting a license application or (1) Identify reestion safety problems; 6
institution, a ve or disapprove minor a
uset for amendment or renewal: or (2)IniWate, raaa== mad or prodde changes in to ation safety procedures i) Review pursuant to $ 35,13 (b)(1) correctin actions and that are not potentiaUy importent to I through (b)(4), on the basis of the board (3} yergfy t=pla==tation of safety with the advice and consent of certi6 cation, the licones, ce the permit correcdve actions.
management: and identifying an individual, and approve (b) A tha=== ebau establieb and (7) For medical use at a medical or disapprove any individual prior to E state in writing b authorities, duties, institution, assist the Radiation Safety allowing that individual to work as an Comunittee in the performaane of it:
authorised user or authorised nuclear E responsibihhee, and ra6 anon safwy pharmacist:
oc6Wues of the Rasauon Safety duties.
OfBoer, and at a ene& cal institution the 93523 fleeseen sessey cesummene.
Radiation Safety Comunittee, and retain Each medical institution licennee shau the current edition of these statemente estabheh a Radiation Safety Comunittee u a record unul b Comm6sion to oversee the use of byproduct (3) Review on the basis of esfety, and kraine'" &* h***
material.
approve with the advice and consent of 6as.as supe (a) Each Committee must rneet the -
the Radiation Safety Omcer md the following administrative requiremente:
management representatiw, ar (a) A licensee that permits the receipt, (1) Membership must consist of at disapprove minor changes in radiation pumeion, use, w trenefw di byproduct ev least three individuale end must include safMy procedune eat am ut mWdal by an in&Wdual umsw b an authorized user of each type of use poWnhaHy imponent to safety and an supervision of an authorised user as l permitted by the license, the Radiation permined undu I 3541 of his Part allowed by 9 35.11(b) of this part shall; f Safety Omcor, a representative of the H) ReWw quane4, wie se E nursing service, and a representative of 31 assistance of the Radiation Safety (1) lastruct b sa,-U indiddual management who is neither an l Officer, a summary of the occupat.onal in the principin of radianon ufety authortsed user not e Radiation Safet f radiation dose records of au personnel appropriate to that indi~idual's use of
[~
Officer. Other members may be incl s working with byproduct material;
(
as the licensee deems appropriate.
(5) Review quarterly, with the byproduct material and in the licensee's f
written ganhty====g==aat
- 5*'**** ? ee Ra&auon Safety g (2) Require the supervloed vidual (2) The Comunittee must meet at least qurudy.
Officer, all incidente involving g to follow the instruc6cas of the (3) To establieb a quorum and to byproduct material with respect to e _ _ _, - - authortsed usw. foBow h conduct bwasaa at least one-half of b cause and subwqwnt actions taken:
g =wr,itwo rdieuon niety and quauty Committee's memborahip must be and present, including the Radiation Safety
@) Redw annuaHy, with es
===pament procedures established by Omcw and b mangemat's assistance f the Radiation Safety the boensee, and comply with the mpmmuum Omcer, the radiation safety program.
regulauene of &is chapur and b (4)1he minutes of each Radiation no,,,,
g ua,,,gg,,,,,, g g use of byproduct material; and Safe Committee meeting must indude:
(1) date of the meetmg:
(ii) Members present; fiii) Mee.bero absent:
f-I liv) Sumunary of dehSwetions and St m _
p) pany r,yim b apwymd
(;) n-==aadad actions and the I individual's use of byp: educt material numencal results of all ballots: one E. ad b roonde kept w re8ect sie me.
(vi) ALARA program reviews described in 5 35J0(c).
y 1._
(5) The Comunittee must promptly provide each member with a copy of the meeting minutes, and retain one copy for h duration of the license.
(b) To oversee the use of bcensed material, the Coaunittee must:
(1) Review recommendations on ways to maintain individual and collective doses ALARA:
35-9 September 29,1995
35.25(b) 35.31(b)
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL us.o (b) A licensee t.kat pertnits the
[I as.se Aementeereew esguirements thet I n31 neemmen seesty proprem pro tion of byptuct material for
- appsy se the provision of metiae nues.or changes.
cal use by an individual under the g messere servees.
(a) A licensee may make minor m
supervision of an authorised nuclear g (a)ne Commission will heense changes in radietion safety procedures pharmacist or physician who is an
- mobile nuclear meJicine service only in that are not potentially important to authorized user, as tilowed by accordance with Subpt.rts D. E and H of safety, i.e., ministerial changes, that
$ 35.11(c), shall:
,,,this part and i 31.11 of this chapter, were described in the opph:stion for license, renewal, or amendment except (1) Instruct the supervised indivioual (b) Mobile nuclear medicine service f r those changes in iI 35.13 and 35.e06 in the pnparation of byproduct material licensees shall obtain a letter signed by of this part. Examples of such for medical use and the principtw of the management of each chent for which ministerial chanate include: editing of o
and procedurn for radiation safety and services are rendered that authorizes proceduns for clarity or conformance in the licensee's written quality t un of byproduct material at the client's with local drafting poDcy or updaung management program, as appropriate to ! address of use.ne mobile nuclear nemet telephone numbers, and
,, that individual's use of byproduct
" medicine service licensee shall retain addresses: adoption of model radiation a
R rnatoriah the letter for three
- after the isst
- fe procedures pubhshed in NRC
[o (2) Require the supervised individual provision of service story Guideo: replacement of it to follow the instructions given f equipment: reassignment of tash among 3 pureuant to paragraph (b)(1) of this (c)If a mobile nuclear medicine employees: or assignment of ser vice section and to comply with the service provides services that the client regulations of this chapter and license is also authorized to provide, the client g contracts for services such as personnel condftfons: and is responsible for assuring that services ;; dosimetry radiation safety equipment repair or calibration. waste disposal, t3) Require the supervising authorized W are conducted in accordance with the nuclear pharmacist or physician who is 3 regulations in this chapter while the and safety surveys. A licensee is an authorised user to periodically 2 mobile nuclear medicine service is responsible for assuring that any change under the c!1ent's direction.
made is in compliance with the review the work of the supervised a
2 (d) A mobile nuclear medicine service requirements of the regulations and the individual as it pertains to re g
byproduct material for m use and may not order byproduct material to be ifcense.
the records kept to reflect that. work.
dehvered directly from the manufacturer (b) A licensee shall retain a recoru of or distributor to the client's address of each change until the bcense has been renewed or terminated. We record must use.
include the effective date of the change, (c) A licenne that supervises en a copy of the old and new radiation individual is responsible for the acts and ufsty procedures, the reason for the omissions of the supervised individual.
change, e summary of radiation safety matters that were considered before making the change, the signature of the Radiation Safety Officer, and the signatures of the affected authorized users and of management or,in a
$ 35.27 [ Removed 59 FR 61767.]
medwalinstitution, the Radiation Safety Committee's chairman and the management repenentative.
O September 29,1995 35 10
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL f'
~
i latas Quamey menessment preysm.
f (2) That prior to each administration, the review,in an auditable form for
\\
(a) Each applicant or licensee under s the patient's or human research three years, this part. as applicable, shall establish $ subject's identity is verified more (c) The licensee shall evaluate and and maintain a written quality
- than one method as the indiv dual respond. *vithin 30 days after discovery management program to provide high
- named in the written directive; of the recordable event, to each confidence that byproduct material or S
recordable event by:
radiation from byproduct material will (1) Assembling the relevant facts be administered as directed by the includms the cause; authorised ustr. De quality (2)Idenhfying what if any, corrective management program must include (3)Th t final plans of treatment and action is required to prevent recurrence:
written policies and procedurse to meet related calculations for brachytherapy.
and E the followir.3 specific objecto l'I'. therapy, and gamma stereotactic (3) Retaining a record,in an auditable a:
A radiosurgery are in accordance with the fonn for three years, of the relevant E wn(1) That, prior to administrauon. a respective wntten directives; facts and what corrective action. If any.
tten directive 8 is prepared for:
3 (i) AJiy teletherapy radiation dose:
(4) That each admirustration is in was taken.
(ii) Any gamme stereotactic g accordance with the written directive; (d) ne licensee shall retain:
radiosurgery radiation dose-A and (1) Each written directive; and (iii) Any brachytherapy radiation 5 (5) That any unintended deviation (2) A record of each administered from the wntten directive is identified radiation dose or radiopharmaceutical dose-g (iv') Any administration of quantities and evaluated, and appropnate action is dosage where a written directive is greater than 30 microcunes of either taken.
required in paragraph (a)(1) above in an sodium iodide I-125 or 1-131: or (b) The licensee shall:
, auditable form, for three y-an after the (v) Any therapeutic administration of (1) Develop procedures for and g date of ac' ministration.
a radiopharmaceutical, other than conduct a review of the quality A le) De licensee may make sodium iodide 1-125 or 1-131:
management program includmg. since g modifications to the quality the last review, an evaluation of:
. management program to increase the
- program's 6fficiency provided the 4
program's effectiveness is not
[-
decreased, ne licensee shall fumish the 0; (i) A representative sample of patient mo8ification to the appropriate NRC
- and human research subject Regional Office within 30 days after the E administrations, modification has been made.
i (f)(1) Each applicant for a new license, i
S as applicable, shall submit to the i
g
[
sppropiate NRC Regional Office lii g
accordance with to CI'R 30.8 a quality management propas as part of the application for e dense and implement the piogram upon eriuance of sne license by the NRC.
(2) Each axis licensee, as (ii) All recordable eventa, and applicable, shall e bmit to the (iii) Allmisadministrations appropriate NRC Regional Office in to veri compliance with all aspects of accordance with to CPR 30.8 by January the que ity management program: these 27 teg2 a written certification that the reviews shall be conducted at intervals quality management program has been g no greater than 12 months; implemented along with a copy of the t If. bece ee of the paneers condtuen. e deter m g
order is prende a wnna mm.on is a emune (2) Evaluate each of these reviews to program g
wnaen *=ctia =euse mpanum uw penai e determine the effectiveness of the Nw"wA"m"**e",i. e M"m"e""me oret
$ quahty management program and,if rewtonen u documenied leunedumly a the petwn a required. make modifications to meet acord and a consed wanen direenn u siened by the objectives of paragraph (a) of this
,i 38.33 ma'a===*='= = reparte, and reasses e nesse, mass,,mene, gsemon ed une wnhm es h-of m mi section and (a) For a misedministration:
Alu. e wnum remton 2 en eutme wroten
() e i M ords of each Mview, direcuve oney be made for say disonestic o, including the evaluationa and findmga of therepsutic prosedure provide 4 Jtet the rewteten te daied sad etened by en authMeed St petor to the administreuen of 'he re36cphernieceutteel deseos.
the brachytherepy wee. the samme etereotectic redissurgery dese. the telethorapy does, or the neat teletherapy frecnemel dese.
tr. because of the emergent nature of the patient's condtiten. e doney in order to prende a wr" ten dirocuve would jeopardsee the penent a hsA en oral directive win be acceptable prended that the Informenon contemed m the oral dirocan le docuenented inunedstely in the penent a record and a written dirvenn is prepared wuhin 24 heure of the oral direcuve-(
35 11 September 29,1995
35.50(a) 35.33(a)
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL (t)The beensee shall notify by 1o notify the individual without first fl3L46 Suppliers for sealed neuroes or oevtoes he medicaluse.
8 telephone the NRC Operations Center :
consulting the referring physician. If the A licensee may use for medical use 3 no later than the next calendar day afte' referring physician or the individus!
E discovery of the misedministration-receiving the misadministration cannot ordy:
(a) Sealed sourcme or devices be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee manufactured, labeled, packaned, and shall notify the individual as soon as distributed in accorrlanca witis a limnse L
possible thereafter. The licensee may issued pursuant to 10 CFR Part 30 and not delay any appropriate medical care 10 CFR 32,74 or the equivalent for the individual, including any
}uinments of an Agreement State; or) T necessary remedial care as a result of the misadministration,because of any and distributodin accordance with a delay in notification.
hcense issued pursuant to 10 CFR Part
( >(2) The licensee shall submit a written(4)If the individual was notified.the @ 30 or the equivalent requirements of an report to the appropriate NRC Regional licensee shall siso furnish, within 15 Gi Agreement State.
Office listed in to CFR 30 6 within 15 days after discovery of the days after discovery of the E
misadministration. The written report misadministration, a written report to g
must include the licensee's name; the the individual by sending either:
prescribing physician's name; a brief (i) A copy of the nport that was description of the event; why the event submitted to the NRC; or Subpart C-Genet 1millachn6 cal occurred; the effect on the indiWdual gequenenta who received the misadministration:
(til A bricidescription of both the what improvements are needed to event and the consequences as they may prevent recurnnee; actions taken to affect the individual, provided a
$ 35.50 Poesema6on, use, cailtaration, and prevent recurrence; whether the
,, statement is included that the report checit of dose centwetors.
beensee notified the individunt for the y submitted to the NRC can be obtained dose calibrator to measure the activity of (a) A licensee shall possess and use a ipve a nuponwe relanve or
- from the bcensee.
g ruardianland if not wny not: anAJf dosages of hoton emitting
^ > - " en * (b) Each licensee shall retain a record radionucli es prior u :ci sistration to g Ecre was notiwa+>-
- aas provideLThe report must nog g of each misadministration for 5 years.
each patient od.uman research subject.
E contam the individual's name or any The record must contain the names of S other information that could lead to all individuals involved (including the identification of the mdividual. To meet Presenbing physician, allied h=alth the requirements of this_section, the personnel, the individual who received hotihcotion of the indmdual receiving the misadministration, and that u.
The misadministronon mav ne m individra's referring physician,if instead to thatindividual's responsible applicable), the individual's social relative or guerman, wnen appropnate.
security number or other identification (3) ne licensee shall notify the number if one has been assigned, a brief refernng physician and also notify the description of the misadministration, individual receiving the why it occurred. the effect on the misadministration of the individual, improvements needed to misadministration no later than 24 prevent recurrence, and the actions hours after its discovery, unless the refernas physician personally informs taken to prevent recurrence, the licenses either that he willinform (c) Aside from the noti *suon the individual or that, based on medical "9"i"" " "ngn this sectiori judgement. telling the individual would affects any rights or dution of licensees be harmful, he licensee is not required and physicians in relation to each other, to individuals receiving misadministrations, or to that individual's responsible relatives or guardians.
dhe comew,cial teiophone numbe, of the NRC O
o,.,.n ce,u... nonsia.s m 3512 September 29,1995
35.50(b) 35.51(d)
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL 0
(b) A bcensee shall:
(1) For paragraph (b)(1), the model i M.51 Camromon and check of survey I
(1) Check each dose cabbrator for and serial number of the dose calibrator, insenananes.
constancy with a dedicated check I the identity of the racionuclide (a) A licensee shall calibrate the source at the begmning of each day of M contained in the check source, the date survey instruments used to show use. To satisfy the requirement of this E of the check, the activity measured, and compliance with this part before first paragraph, the check must be done on a ; the initials of the individual who use, annually, and following repair. The frequently used setting with a scaled performed the check:
licensee shall:
source of not less than to microcunes of radium.226 or 50 microcuries of any (1) Cahbrate all scales with readings other photon emitting radionuclide; up to 1000 millirem per hour with a todtation source:
3 (1) Test each dose cabbrator for (2) For parsgraph (b)(2) of this sectioc (2) Calibrate two separated readings 8 accuracy upun installation and at least the model and serial number of the dose on each scale that must be calibrated; g annually thereafter by assaying at least calibrato', the model and se ian number
- t'vo sealed sources containmg different of ea
- h source used, the identity of the $and(3) Conspicuously note on the radionuclides whc4e activity the radionuclide contained in the source g instrument the apparent exposure rate manufacturer has determined within 5 knd its activity, the date of the test, the e from a dedicated check source as percent of its stated activity, whose results of the test, and the identity of the
- determined at the time of calibration, activity is at least 10 microcunes for individual performing the test.
and the date c>f calibration.
radium 226 and 50 microcunes for ar,y 4 (3) For paragraph (b)(3) of this section.
(b) When cahbrating a survey other photon emitting radionuclide, and 3 the model and serial nurnber of the dose instrument, the licensee shall consider a at least one of which has a princi: el e calibrator, the calculated activities. the point as calibrated if the indis.ted photon energy be. ween 100 kev and 500 $ measured activities, the date of ti e test, exposure rate differs from the calcdated kev;
- and the identity of the individual exPoure rate by not more than 20 performing the test.
percent, and shall conspicuously attach (4) For parsgraph (b)(4) of this section, a conection chart or graph to the (3) Test each dose calibrator for the model and serial number of the dose instrument.
linaatity upon installation and at least calibrator, the configuration of the (c) A licensee shall check each survey
{o quarterly thereafter over a range from
- the highest dosage that will be source measured, the activity measured instrument for proper operation with the for each volume measured, the date of dedicated check source each day of use.
e administered to a patient or humt.n the test, and the identity of the A licensee is not required to keep
. research subject to 1.1 megabecquerels individual performing the test.
records of these checks.
- (30 microcuries), and
-p o
h (d) A licensee shall retain a record of e each survey instrument calibration for (4) Test each dose cabbrator for y three yearsThe record must include:
geometry dependence upon mstallation i
over the range of volumes and volume L
configurations for which it will be used.
The heensee shall keep a record of this (1) A description of the calibration test for the duration of the use of the procedure; and I
(ose calibrator.
(2) The date of the calibration, a 4 (c) A licensee shall also perform d
4 escription of the source used snd the
- appropnate checks and tests required g certified exposure raterfrom the source, f by this section following adjustment or and the rates indicated by the e
a repair of the dose calibrator.
w instrument being calibrated, the 3 (d) A licensee sheti mathematically 3 correction factors deduced from the correct dosage readings for any calibratwn data, and the signature of the geometry or linearity error that exceeds individual who performed the to percent if the dosege is greater than calibration.
to microcuries and shall repair or replace the dose cahbrator if the accuracy or constancy error exceeds 10 percent.
f (e) A heensee shall retain a record of o each check and test required by this Z section for three years unless directed
[ otherwise. The records required h w paragraphs (b)(1) through (b)(4) of this 2 section must include:
L n
v 35 13 September 29,1996
PART 35 c MEDICAL USE OF BYPRODUCT MATERIAL 635.62 Possesanon. vee, calltwation, and (a) Measure the activity of each (4) Date and time of the measurement.
check of instruments to mearwe dosages dosage of a photon emitting and of alpha or beto-emitting red.onuchdes, radionuclide prior to medical use.
(5) Initials of the ir.dividual who made (a)This section does not apply to unit (b) Measure, by direct measurement or the record.
g y combination of mess rements and b
dosages of alpha or beta erraitting radionuclides that are obtained from a e calculations, the activity of each dosage manufacturer or preparer licensed y of an alpha or a beta +mittin Any person authorized by l 35.11 of pursuant to 10 CFR 32.72 or equivalent - radionuclide prior to medica use, this Part for medical use of byproduct Agreement State requirements.
$ except for unit dosages obtained from a ma'erial may receive, possess, and use manufacturer or parer licensed the following byproduct material for (b) For other than unit dosages obtained pursuant to paragraph (a) of Pursuant to 10 32.72 or equivalent check, calibration ar.d reference usm this section, a licensee shall possess and Agreement State requirements; p (a) Sealed sonces manufactured and use instrumentation to measure the 8 distnbuted by a person licensed radioactivity of al ha or beta-emitting w pursuant to l 32.74 of this chapter or g (c) Retain a record of the
- equivalent Agreenaent State regulations radionuclidea, licensee shall have and that do not exceed 15 millicuries procedures for use of the instrumentation. The licarsee shall y measurements required by this section each
for three yearsTo satisfy this measu*e, by direct measurement or by
- requirement, the record must contain (b) Any byproduct raateriallisted in a
E combination of measuremants a.nd 3
ll 35.100 m 30 ".with a half-life not 3 calculations,the amount of redioactivity l the:
loncer than 100 usys in individual 5 in dosages of alpha or beta +ruitting am unta not to exceed 15 millicunes; e radionuclides prior to administration to (c) Any bypruduct materiallisted in
- each patient or human research subject.
Ii 35.100 or 35.200 with a half life longer In addition, the licensee shall:
than 100 days in individual amounts not (1) Perform tests before initial use, p (1) Generic name, trade name, or to exceed 200 microcuries each; and periodically, and following repair, on e abbreviation of the (d) Technetium Gem in individual M adiopharmaceutical, its lot number, and amounta not to exceed 50 millicunes.
each instrument for accuracy,linearity, r
and geometry desondence, as f expiration dates and the radionuclide; appropriate for the use of the E
instrument: and male adjustments when necessary; and (2) Check each instrument fx constancy and proper operation at the (2) Patient's or human research beginning of each day of use, subject's name, and identification a number if one has been assigned; 2 (3) Prescribed dosage and activity of E the dosage at the time of measurement, y or a notation that the total activity is a less than 1.1 megabecquerels (30 638.53 Measurement of dosepes of microcunesh unseele i byproduct mesertal for mediosi ues.
F l
Aiicenseesh.ii:
E s
L O
sepwmber 2s,1995 3544
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL n
F i 36.00 hoguirementa let poseeeelen of (2)l' ale a report withm five daya of the g i 35.60 Syrtnge erno6es and lahees.
e asased asuroes and lurechysherapy seuroes.
leakage test with the appropnate NRC a A licensee shall keep syringes that g (n')ain byproduct material to be (a) A licensee in possession of any Office hsted in i 30.6 of this chapter.
co g
sealed source or brachytherapy source
- with a copy to Director, Office of Nuclear administered in a radiation shield.
i shall follow the radiation safet and Material Safety and Safeguards. l!.S.
m handling instructions supplied y the e Nuclear L
manufacturer, and shall maintain the g Regulatory Commission. Washington.
l 1.astructions for the duration of source DC 20555. desenbing the equipment (b) To identify its contents, a heensee use in a legible form cornenient to users.
involved. the test results, and the action shall conspicuously label each syringe (b) A licensee in possession of a taken.
or syringe radiation shield that contains sealed source shall:
a r/ringe with a radiopharmaceutical.
(1) Test the source for leakage before The label must show the its first uur unless the licensee has a radiopharmaceutical name or its certifk. ate from the supplier indicating (f) A bcensee need not perform a that the source was tested within sit leakage test on the following sourt es:
abbreviation, the clinical pro.,cedure to 9
g,
,g g,, g o
cn ng y pr et months before transfer to the licensee; human research subject's name.
and (c) A licenses shall requin each (2) Test the source for leakage at day ' Sources containmg only byproduct E ndividual who prepares a i
g2) intervata not to exceed six months or at material as a gas; E radiopharmaceutical kit to use e eyringe other intervals approved by the (3) Sources containing 100 microcuries radiation shielt! when
't, the kit Commission or an Agreement State and or less of beta or gamma. emitting and shall uim each vidal tme i
described in the label or brochure that material or 10 microcuries or less of a syringe ta lation shield when accompanies the source.
alpha. emitting matertal:
administering a radiopharmaceutical by (c) To satisfy the leak test (4) Sources stored and not being used.
injection unless the use of the shield is' 4
requirements of tbs section, the licensee The licensee shall, however, test each contraindicated for that patient or must such source for leakage before any use human research subject, g (1)Take a wipe semple from the or transfer unless it has been leakage-g sealed source or from the surfaces,of the teued within six months before the date
,. device in which the sealed source is.
of use or transfen and g mounted or stored on which radioactive
- 5) Seeds of indium.192 encased in e contamination might be expected to
$ ny(lon ribbon.
g 35.st viel shoekse and Ishoes.
accumulate or wash the sourc-in a g (g) A licensee fn possession of a (a) A licenser shall require each sma!! volume of detergent solvion and e sealed sourse or brachytherapy source individual prepantig or handling a vial tr;st the entire volume as the sample; y shall conduct a quarterly physical that contains a radio harmaceutical to i
c.
(2) Take teletherapy and other devic' inventory of all such sources in its E keep the viat in a via radiation shield.
source test samples when the source is possession. The licensee shall retain x
(b) To identify its contents, a licensee in the 'off' position: and each inventory record for five years. The 5 shall conspicuously label each vial (3) Measure the sample so that the inventory records must contain the leakage test can detect the presence of model number of each source, and serial 'n radiation shield that contains a vial of a radiopharmaceutical. The label must 0.005 microcunes of radioactive matenal number if one has been assigned. the show the radiopharmaceutical name or on the sample.
identity of each source radionuclide and hsabb W a wn.
(d) a licensee anall retain leakage test its nominal activity, the location of each records for five years. The records must source, and the signature of the contain the model number, and senal Radiation Safety Officer.
number if assigned, ci each source (h) A licensee in possenion of a tested. the identity of each source sealed source or brachytherapy source radionuchde and its estimated activity, shall measure the ambient dose rates the measured activity of each test quarterly in all areas where such sample expressed in microcunes, a sources are stored. This does not apply desenption of the method used to to teletherapy sources in teletherapy i
measure each test cample, the date of units or sealed sources in diagnostic the test, and the signature of the devices.
Radiation Safety Officer.
(e)if the leakage test reveals the presence of 0.005 microcune or more of (i) A licensee shall retain a record of removable contamination, the licensee each survey required in paragraph (b) of shall:
thia section for three years.The record (1)Immediately withdraw the sealed 9 must include the date of the servey, a source from use and store it in 5 plan of eacn area that was surveyed, the measured dose rate at several points in accdance with the requirements in e
Parts 20 and 30 of this snapter; and
- each area expressed in millirem per e haur, the survey instrument used, and the signature of the Radiation Safety
'~
Officer.
4
(
L 35 15 September 2% W
35.70(a) 35.75(di PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL
$ 35.70 Surveys for contamination and effective dose equivalent to any other ammtent remon earwm men.
Individualis likely to exceed 1
( ) A licensee shall survey with a millislevert (0.1 rem). If the dose to a radiation detection survey instrument at breast feeding infant or child could the cnd of each day of use all areas exceed 1 millislevert (0.1 rem) assuming where radiophar:naceuticals are them were no interruption of breast.
r:utinely prepared for use or feeding, the instructions shall also tdministered.
include:
(b) A licensee shall survey with a (1) Guidance on the interru tion or radi: tion detection survey instrument at discontinuation of breast. fee ng and tadiop$armaccu is o (2)Infonnation on the consequences r:diopharmaceutical waste is stored.
of failure to follow the guidance.
(c) A licensee shall conduct the (c) The licensee shall maintain a surveys required by paragraphs (a) and g record of the basis for authorizing the (b) cf this section so as to be able to
- release of an individual, for 3 years after detect dose rates as low as 0.1 millirem g the date of release,if the total effective per hour.
dose equivalent is calculated by:
U g (d) A licensee shall establish radiation (1) Using the retained activity rather
= dose rate trigger levels for thw surveys than the activity administered, f required by paragraphs (a) and (b) of
- u. this section. A licensee shall require that (2) Using an occupancy factor less than 0.25 at 1 meter, in the individual performing the survey immediately notify the Radiation Safety (3) Using the biological or effective Officer if a dose rate exceeds a trigger half-life, or lev:1.
(4) Considering the shielding by
(:) A licensee shall survey for tissue.
rem:vable contamination once each (d) The licensee shall maintain a week all areas where record for 3 years after the date of radiopharmaceuticals are routinely release, that instructions were provided prepared for use, administered. or to a breast. feeding woman if the stored.
radiation dose to the infant or child (f) A licensee shall conduct the from continued breast. feeding could surveys required by paragraph (e) of this result in a total effective dose equivalent section so as to be able to detect exceeding 5 millisleverts (0.5 rem).
contamination on wach wipe sample of 2000 disintegrations per minute.
(g) A licer.eee shall establish removable contamination trigger levels for the surveys required by paragrapa (2) of this section. A licenace shall
$ 35.75 Release of Individuale containing require that the individual performing r&Gef.. ~eaticals or permanent the survey immediately notify the implants.
j Radiation Safety Officer if 5 (a) The l'censee may authorir.e the contamination exceeds the trigger level.
release from its control of any individual who has been administered g radiopharmaceuticals or permanent (b) A licensee shall retain a record of ; implants containing radioactive material each survey for t'hree years 'Ite record E if the total effective dose equivalent to g any other individual from exposure to l must include the date of 'the survey. a plan of each area surveyed. the tngger the released individualis not likely to o level established for each area, the exceed 5 millisieverts (0.5 rem).*
A detected dose rate at several pomts in (b) The licensee shah provide the
- each area expressed in milkrem per released individual with instructions.
E hour or the removable contamination in including written instructions, on 2 each area expressed in disintegrations actions recommanded to maintain doses per minute per 100 square centimeters, to other individuals as low as is the instrument used to make the survey reasonably achievable if the total cr cnalyze the samples, and the initials cf thiindividual who pedormed the 1Ragula Guide s.39.* Release of Patients Administ Radioactive Materials." describes
- surviy, methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding s milhsieverts (0.s rem).
January 31,1997 35-16
35.80 35.92(b1 PART 35
- MEDICAL USE OF BYPRODUCT MATERIAL o
=
[N l 36.00 Technical requirements that apstf (f) Retain a record of each survey to the provtsien of metene nuclear medleine required in paragraph (e) of this section
( j) -
g
- servios, g for tritt e seat. The tecord must include A licensee providing mobile nuclear g the date of the survey, a plan of each area that was surveyed, the neasured
- dose rate at several points in each area medicine service shall
(a) Transport to each address of use u.
only syringes or vials containing 2 of use expressed in milbrem pcr hour, prepared radiopharmaceuticals or the instrument used to make the survey, radiopharmaceuticals that are intended and the initials of the individual who for reconstitution of performed the survey, radiophannaceutical kita:
(b) Bring into each address of use all l 6 35.90 Storage of volatsee and geoes, byproduct material to be used and.
E A licensee shall store volatile betore leaving. remove all unused l radiopharmaceuticals and radioactive byproduct material and all associated a gases in the shipper's radiation shield p w aste;
$ and container. A licensee shall store a c Secure or keep under constant
- multi-dose container in a fume haod k su(rv)eillance and immediate control all Larter drawian ihe firsi dosa e from it-6 byproduct material when in transit or at r l R92 WMw s an addresa of use; l
(d) Check survey instruments and I;; (a) A licensee may hold byproduct dose calibrators as described in il 35.50 R material with a physical half. life of less and 35.51, and check all other e than 65 days for decay.in-storage before transported equipment for proper E disposalin ordmary trash and is exempt function before medical use at each
$ from the requirements of $ 20.2001 of this
{ chapter if it:
address of use; l
(e) Carry a radiation detection surve meter in each vehicle that is being use[
(1) Holds byproduct material for decay a minimum of ten half lives:
l to transport byproduct material, and, before leaving a client address of use, (2) Monitors byproduct material at the survey al' radiopharmaceutkal areas of contamer surface before disposal as rdmary trash and determines that its use with a radiation detection survey radioactivity cannot be distinguished meter to ensure that all fr m the background radiation level radiopharmaceuticals and all associated R with a radiation detection survey meter 8,
waste have been removed.
8 set on its most sensitive scale and with g no interposed shielding:
~
g (3) Removes or obliterates all radiation labels: and (4) Separates and monitors each gererator column individually with all radiation shieldmg removed to ensure that it has decayed to background radiation level before disposal.
I (b) A licensee shall retain a record of each disposal permitted under paragraph (a) of this section for tnree years. The record must include the date 9 of the disposal, the date on which the y byproduct material was placed in e storage, the radionuclides disposed, the A survey instrument used. the background
- dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed
_the disposal.
s
/
%J 35-16a January 31,1997 (reset) enest page n M-171
35.100 35.220 PART 35 e MEDICAL *JSE OF BYPRODUCT MATERIAL
/'
Sut>part 0-Uptake, D6tution, and i 35.204 Permewt se moayt>o.num.,,
(c) Before receiving, using, or sionng
(,
j Escretton concentration.
a radioactive gas, the licensee shall V
(a) A bcensee may not admmister to calculate the amount of time needed humans a radiopharmaceutical after a spill to reduce the concentration
} WOO N,of um W
- contaming more than 015 microcune of
- in the room low enough so as not to g
j,,,,,,n g molybdenum 99 per milhcune of te exceed the limits prescribed by etudies' E c$ 20.1201 of this chapter.The technet;um.99m.
a A licen see may use for uptake.
(b) A hcensee that uses rnolybdenum.
alculation must be based on the highest dilution >r excretion studies any
- 99/ technetium 99m generators for E activity of gas handled in a single unsealed ayproduct material prepared prepanng a technetium 99m container, the air volume of the room, for medical use that is either
radiopharmaceutical shall measure the and the measured available air eshaust 3 (a) Obttined from a manufacturer or molybdenum-99 concentration m each rate' g preparer licensed pursuant to 10 CFR eluate or extract e 32.72 or equivalent Agreement State
% requirements;or (c) A hcensee that must measure (b) Prepared by an authorized nuclear molybdenum concentration shall retain (d) A bcensee shall make a record of
+5 pharmacist, a physician who is an a record of each rneasurement for tnre, the calculations required in paragraph authorized user and who meets the years. The record must include, for each c of this section that includes the uirements specified in $ 35.920, or an 3 elution or extraction of technetium.99m.
Q (as)sumptions measurements, and ividual under the supervision of a the measured activity of the technetium m
expressed in milhcunes. the measured f calculations made and shall retam the either as specified in $ 35.25.
record for the duration of use of the ew activity of the molybdenum expressed in w
2 microcuries the ratio of the measures s area. Alicensee shall also post the expressed as mier curies of calculated time and safety me.sures to i
I 35.12o Possession os survey instrument.
molybdenum per milhcune of be instituted in came of a spill at the area A he ensee authonzed to use technetium the time and date of the of use.
g byproduct matenal for uptake. dilution.
measurement and the initials of the 4
g and excretion studies shall have m its ndividual who made the measurement.
" possession a portable radiation
["'
E detection sursey instrument capable of l
e A heensee shallcheck the
$ op(er)ation of reusable collection system l
5 detectmg dose rates over the range 0.1
$ 35.205 Control of aerosota and gases' milhrem per hout to 100 milbrem per (a) A licensee that administers R each month, and measure the ventilation hour.
radioactive aerosols or gases shall do so e rates available in areas of radioactive
. In a room with a system that will kMp $ gas use each six months.
?o airborne concentrations low enough so p
j as n t to exceed the limits prescribe? by {
I Sutspart E-imaging and Locattaation
%$ 20.1201 and 20.1301 of Ihis chapter.
w g
$ The system must either be dires tly l 35.220 Poseeeston of survey
$ 35.200 use of unsealed tryproduct vented to the atmosphere through an air in,,,,,,,,,,
metertal for imaging and locantation exhaust or provide for collection and A licensee authorized to use studies.
decay or disposal of the aerosol or nas byproduct material for imaging and A licensee may use for imaging and in a shielded container, locahzation studies abe!1 have in its i
localization studies any unsealed E possession a portable radiation byproduct material prepared for medical l-
$ detection survey instrument capable of 3 use that is either:
(b) A heensee shall administer e detecting dose rates over the range of g (a) Obtained from a manufacturer or $ radioactive gases only in rooms that are I 0.1 millirem per hout to 100 millirem per e preparer bcensed pursuant to 10 CFR R at negative pressure compared to
- hour, and a portable radiation
% 32.72 or equivalent Agreement State E surroundmg rooms-measurement survey instrument capable
- requirements; r'r 2
of measuring dose rates over the range 1 (b) Prepared by an authorized nuclear millirem per hour to 1000 millirem per hour.
pharmacist, a physician who is an authorized user and who meets the i
requirements specified in 5 35.920, or an individual under the supervision of either as speciSed in 6 35.25.
J b
35 17 Wber 29, W95 2
35300 35315(b)
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL Subpert F-Radiopharmaceut6cals fo, Fi35.345 satety precautions.
(5) tithe, monitor materiai and iiems h*PY E
a For each patient or human removed from the patient's or the
" res(ea)rch subject receiving human research subject's room to g
s
$ 35.300 Use of uneenied byproduct g radiopharmaceutical therapy and R determine usat their radioactivity cannot moeorialfor
- m administrocon, o, hospitalized for compliance with e be distinguished from the natural A licensee may use for therapeutic l 5 35.75 of this chapter, a licensee shall: E background radiation level with a administration any unsealed byproduct L-g radiation detection survey instrument mat; rial prepared for medical use that is r-set on its most sensitive scale and with I
n interposed shielding, or handle them ith (abtained from a manufacturer or 0
t ary f c 11 preparer licensed pursuant to 10 CFR 8 pn 32.72 or equivalent Agreement State E
requirements; or (b) Prepared by an authorized nuclear {
> (6)(Reserved 62 FR 4120.)
pharmacist, a physician who is an authirized user and who meets the
~
s pa nsr uman
,, requirements specified in 6 35.920 or an E individual under the supervision of research subject's door with a G cithrr as specified in $ 35.25*
" Radioactive Materials" sign and note (7) Surve the patient's or the human on the door or in the patient's or human research su lect's room and pnvate e
g research subject's chart where and how sanitary facility for removable
- long visitors may stay in the patient's or contamination with a radiation s
$ 35.310 Safety instruction.
- the human research subject's room; e detection survey instrument before (a) A licensee shall provide radiation ; (3) Authorize visits by individuals E assigning another patient or human safety instruction for all personnel a under age 18 only on a case.by-case E research subject to the room. The room caring for the patient or the human basis with the approval of the g must not be reassigned until removable research subject roeiving authorized user aher consultation with contamination is less than 200 radiopharmaceutical therapy and the Radiatica Safety Officer; disintegrations per minute per 100 square centimeters; and hospitalized for compliance with 5 35.75 of this chapter. To satisfy this
~
requirement the instruction must describe the licensee's procedures for:
(4) Pr mptly after administration of (8) Measure the thyroid burden of (1) Patient or human research subject the dosage, measure tne dose rates in each individual who helped prepare or control; contiguous restncted and unrestricted administer a dosage of lodine-131 within areas with a radiation measurement three days after administering the
{
survey instrument to demonstrate g dosage, and retain for the period e mphance with the requirements of
$ required by $ 2n2106(a)of 2
(2) Visitor control'-
o 8
(3) Contamination control; g Part 20 of this chapter, and retain for e this chapter a record of each 5
(4) Weste control; and g three years a record of each survey that ' thyroid burden measurement,its g includes the time and date of the survey, S date, the aame of the individual whose g
g a plan of the area or list of points thyroid burden was measured, and the surveyed, the measured dose rate at initials of the individual who made the
{
several points expressed in millirem per measurements.
hour, the instrument used to make the g (5) Notification of the Radiation s
survey, and the initials of the individual
- Safety Officer in case of the patient's or who made the survey.
e the human research subject's death or
- medient emergency.
3 (b) A licensee shall ncaify tha g Radiation Safety Officer immeciately if
[
e the patient or the human research g subject dies or has a medical emergency.
(b) A licensee shall keep for three years o a list c f individuals receiving instruction j required by paragraph (a) of this section, m desenption of the instruction, the date Ec f instruction, and the name of the 2individ tal who gave the instruction.
L O
January 31,1997 35-18
1 35320 35.406(d)
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL 4
g i 36.330 Paaa===a~i of survey
$ 35.a04 Release of patients or human 5 35.a06 Brachytherapy sources inventory, i f beansnenen, research suMocts treatemth temporary (a) Promptly after removing them i
A licensee authorised to use
'*P'*"'**
from a patient or a human research byproduct material for (a)Immediately after removing the subject, a licensee shall return radiopharmaceutical therapy shall have last temporary implant source from a brachytherapy sources to the storage in its possession a portable radiation patient or c human research subject, the area, and count the number returned to detection survey instrument capable of licensee shall make a radiation survey of ensure that all sources taken from the detecting dose rates over the range 0.1 the patient or the human research storage area have been returned.
i milhrem per hour to 100 millitem per sub ect with a radiation detection (b) A licensee shall make a record of l
hour, and a portable radiation survey instrument to confirm that all brachytherapy source use which must measurement survey instrument capable sources have bsen removed. The include:
of measuring dose rates over the range 1 licensee may not release from (1) The names of the individuals millirem per hout to 1000 mithrem per
- confineaient for medical care a patient permitted to handle the sources
l hour.
- or a human research subject treated by (2) The number and activity of
- temporary implant until all sources sources removed from storage, the
,, have been removed.
patient s or the human research N
(b) A licensee shall retain a record of subject's name and room number, the
=
I as.4eo use of sources for patient or human research subject time and date they were :emoved from trachriharapy surveys for three years. Each record 3 storage, the number and activity of the o
2 A licensee shall use the following must include the date of the survey, the 3 sources in storage after the removal, and M sources in accordance with the name of the patient or the human a the initials of the individual who E manufacturer's radiation safety and re earch subject, the dose rate from the % removed the sources from storage, a handlms instructions:
patient or the human research subject (3) The number and activity of (a) Cesium-137 as a sealed source in expressed as millirem per hour and sources returned to storage, the patient's needles and applicator cells for topical.
measured at 1 meter from the patient or of the human research subject's name interstitial, and intracavitary treatment the human research subject, the survey and room number, the time and date of cancer:
instrument used, and the initials of the they were returned to storage, the 2
(b) Cobalt 40 as a sealed source in individual who made the survey.
number and activity of sources in needles and applicator cells for topical, storage after the return, and the initials interstitial, and intracavitary treatment of the individual who returned the of cancer:
sources to storage.
(c) Gold 198 as a sealed source in (c)Immediately after implanting seeds for interstitial treatment of cancer; sources in a patient or a human research (d) Indium 192 as seeds encased in subject the licensee shall make a i
nylon nbbon for interstitial treatment of radia' tion survey of the patient or the
\\
cancer.
human research subject and the area of (e) Strontium-90 as a sealed source in use to confirm that no sources have an apphcator for treatment of superficial been misplaced. The licensee shall eye conditions: and make a record of each survey, (f)Iodme 125 as a sealed source in seeds for interstitial treatment of cancer.
E req (d) A licensee shall retain the records w
I
! (g) palledmm-10J.4s a scaled source e section for three years
- m seeds for intershtial treatment of n
g cancee.
L
- r.
t L
l i
35 19 September 29,1995
35.410(a) 35.420 PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL
~
$ 35.410 Safety instruction.
(a) The licensee shall provide
$ 35.415 Safsty precautions.
(b) A licensee shall notify the E radittion safety instruction to all
>> (a) For each patient or human a Radiation safety Officer immediately if E personnel caring for the patient or the research subject receiving implant t: the patient or the human research E human research subject undergoing therapy and not released from licensec ; subject dies or has a medical emergency, g impimt therapy. To satisfy this R control pursuant to $ 35.75 of this part, A requirement, the instruction must I a licensee shall:
describe:
E (1) Not quarter the patient or the 3 human research subject in the same
["~
room as an individual wh;is not 4 (1) Size and appearance of the receiving radiation therapy.
g br:chytherapy sources, (2) Safe handling and shielding g
- instructions in case of a dislodged e source;
, L i=
,F A licensee authorized to use byproduct material for implant therapy R
(3) Procedures for patient or human (2) Post the patient's or human shall have in its possession a portable g research subject control:
research subject's door with a
$ radiation detection survey instrument
" Radioactive Materials" sign and note g capable of detecting dose rates over the on the door or in.he patient's or human e range 0.1 millirem per hour to 100
(_
E research subject's chart where and how I millirem per hour, and a portable E long visitors may stay in the patient's or
- radiation measurement survey e hu instrun. eat capable of m_easuring dose (4) Procedures for visitor control; and h (man research subject's room:
- 3) Authorize visits by individuals rates over the range 1 millitem per hout M
under age 18 only on a case-by-case to 1000 millirem per hour, basis with the approval of the x
authorized user after consultation with i
the Radiation Safety Officer; and eL
_ (4) Promptly after implanting the F (5) Procedures for notification of the material, survey the dose rates in contiguous restricted and unrestricted
~
_ @ Radiation Safety Officer if the patient or areas with a radiation measurement
= the human research subject dies or has survey instrument to demonstrate
' g a medical emergency.
S compliance with the requirements of a Part 20 of this chapter, and retain for 1 o
[
e 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 e
(b) A licensee shall retain for three surveyed. the measured dose rate at
$ ye:rs a record of individuals receiving several points expressed in' millirem per instruction required by paragraph (a) of hour, the instrument used to make the e this section, a description of the survey, and the initials of the individual
= m inshetion the date ofinstruction, and who made the survey.
- % the name of the individual who gave the
- instruction.
~
>> (5)[ Removed 62 FR 4120.]
O January 31,1997 35-20
. _ - - ~ -. -..
t 35.500 35.615(b) f%RT 35 e MEDICAL USE OF BYPRODUCT MATERIAL i
Simport M-Gealed Sewees ter SubperO-Telegierapy (21%e procedure to be followed if;
~
j Olapoeis (i)ne operator is unable to turn the i
I'"' " ' " ' "'"8 "**
tro outsi t taent r a or W
he regulations and provisions of this any other abnormal operetion occure A licensee shall use the f2tiowing subpart govern the use of teletherapy and esaled sources in accordance with the units for medical use that contain a (ii)1k naams and telephone numbere j
manufacturst's radiation safety and sealed source of cobalt go or coelum.i.
of the authorised users and Radiation handhng instructions Safety Officer to be i==aA=tel i
l (a) lodine 138, americium 341, or IasAss mandmeer g contactedif the telethere un't or
(
gadolinium.183 as a sealed source in a E console operates abnorn y,
i device for bone mineral analyste; and Only a person specifically licensed by (b) A licensee shah provide the ra==laaien or an Agmment State instruction in the topics identifled in i
(b) lodine-tal as a sealed source in a to germ talethmpy M maintaance paragraph (a) of this section to all l-l portable imaging device and repair shah:
individuels who operate a teletherapy j
y $ SSJeg Aessseggy of eureer heetseent.
(a)lastall, relocate, or remove a unit.
! A limanae authorised to use teletherapy sealed source or a I
g byproduct mater'd w a sealed source teletherapy unit that contains a osaled
{ (c) A licenm shall retain for three l
for diagnostic purposes shall have souros; or available for use a portable radiation (b) Malntain, adjust, or repair the I years a record of individuals receiving detection survey instrument capable of source drewer, the shutter or other instruction required by paragraph (b) of detecting dose rates over the range 0.1 mechanism of a teletherapy unit that I this section, a description ni the i
l millirem per hour to too millitem per
$ could expose the source, reduce the E instruction, the date of instruction, and
{
bour or a portable radiation R shielding around the source, or result in 2 the name of the individual who gave the measurement survey instrument capable ! lacmased raaiation levels.
l instruction.
j of measuring does reles over the range 1 E I--
g gg,ggg millirem per hour to 1000 millitem per i
j hour.De instrument must have been la addition to the changes specified in j
calibreted in accordance with I 35.51 c; I 38.13 of this part, a licensee shall I as.sts seteer pressumene.
this part, apply for and must receive a license (a) A licensee shall control access to amendment before:
the teletherapy room by a door at each (al Making any change in the entrance.
treatment room shielding:
(b) A licensee shall equip each (b) Making any change in the location entrance to the teletherapy room with
\\
of the teletherapy unit within the an electrical interlock system that will:
j treatment room; g (1) prevent the operator from turning l
(c) Using the teletherapy unit in a R the primary beam of radiation on unless eat.h treatment room satrence door is manner that could result in increased g
i radiation levels in areas outside the
$ closed, i
teletherepy treatment room:
(2) Turn ;he primary t4am of radiation l
(d) Relocating the teletherapy unit; or off imunediately when an entrance door (e) Clowing an individual not listed is W and on the licensee's beense to perform the (3) prevent the primary beam of duties of the teletherapy physicist.
radiation from being turned on foHowing 4
i an interlock interruption until all 936414 gasesy eneouseen.
treatment room entrance doore are (a) A licensee shall poet instructions closed and the beam and controlis reset at the console.
l at the teletherapy unit console.To 4
satisfy this requirement, these instructions must inform the operator of:
l j
f (1) The procedure to be followed to
~ ensure that only the patient or the 4
j E human ressarch subject is h the
- treatment room before turning the 4
primary beam of radiation on to begin E a treatment or after a door interlock l
Latorruption:
~
i i
4 i
i 35-21 Septomiser 29,1995 1
i
35.615(c) 35.630(c)
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL (c) A licaneee shall equip each (e) A licensee shall construct or equip
= (1)W sbstem must have been cahbrated y the National Institute of entrance to the teletherapy room with a Os each teletherapy room to permit beam condition indicator hght.
g continuous observation of the patient or Standards and'!echnology (d) A licenue shallinstallin uch a the human rmarch subject from the or by a cahbration laboratory teletherapy room a permanent radiation % teletherapy unit console during accredited by the Amencan Association monitor capable of continuously
- irradiation, of Physicists in Medicme ( A APM). The monitonns beam status.
[
cahbration must have been performed (1) A radiation momtor must provide within the previous No years and after visible notice of a taletherapy unit any serviems that may have affected system cahbration; or a malfr.nction that results in an exposed I or Tartia!!y exposed source, and must be i35620 Poseeedon of survey betrument, (2) W system must have been cahbrated withm the previous four
" observable by an individual entenna the A licensee authonzed to use
'. telotherapy room.
byproduct matenalin a teletherapy unit years: eighteen to thirty months after (O A radiation monitor must be shall have in its possession either a that calibration. the system must have bun inmompared at an equippd with a backup power supply portable radiativi detection survey separate fna the power supply to the instrument capable of detecting dose mtercomPanson meetmg with another teletherapy unit. This backup power N rate over the range 0.1 millirem per hour dosunetry system that was cahbrated within the past twenty four months by supply may be a battery system.
Q to 100 millirem per hour or a portable the National Institute of Standards and g radiation measurement survey 8
' instrument capable of measunns dose g Techriology or by E rates over t'.e range 1 milhrem per hout y a calibration laboratory accredited by (3) A radiation monitor must be to 1.000 milbrem per hour,
- u. the AAPM. W mtercomparison
~
E checked with a dedicated check source
$ muting must be sanctioned by a ca su n la t n or uddogic 3 or proper operation each day before the f
h,$,*d,"g'g[*i,,,j,,Y,'h',
'*d D
5 teletherapy unit is used for treatment of I as.s3e oesemetry equement.
n,
$ patients or hurnan research subjects-(e) A heensee shall have a cabbrated meeting must have indicated that the dosimetry system available for use. To cahbratica factor of the hcensee's satisfy this requirement one of the system had not changed by more than 2 following two conditions must be met.
percent. The hcensee may not use the (4) A bcensee shall maintain a record mtercompanson result to change the cahbration factor. When intercompenna of the check required by paragraph dosinetry systems to be used for g (d)(3) of this section for three years. The cahbratmg cobalt.eo teletherapy units.
g record must include the date of the the licensee sha.1 use a teletherapy unit a check notation that the monitor with a cobal 40 source. When n indicates when its detector is and is not intercompenna dosimetry systems to be exposed, and the initials of the used for cahbrating cesium.137
,andividual who performed the check.
teletherapy unita, the hcensee shall use a teletherapy unit with a cesium.13?
(3)lf a radiation monitoris source.
inoperable. the licensee shall require any individual entering the teletherapy room to use a survey instrument or ib) The hcensee shall have available audible alarm personal dosimeter to for use a doebnetry system for spot.
monitor for any malfunction of the check measurements. To satisfy this source exposure mechanism that may mquirement, the system may be result in an exposed or partially compared with a system that has been exposed source.N instrument or calibrated in accordance with paragraph doeinster must be checked wtth a (a) of this section. This compenson must dedicated check source for proper have been performed within the operation at the beginning of each day previous year and after eau servicing of use N bcensee shall keep a record a that may have affected system 2 as described in persgraph (d)(4) of this
- calibration. The spot. check system may section.
" be die same system used to me et the a
N (6) A licensee shall promptiv repair n s mquimmentin paragraph (a)of this 3
e radiation monitor if it is 3"
Og of ear.h cabb>ation.intercomparison.
and comparison for the duration of the license. For each calibration.
intercomparison. or comparisorm the record must include the date the model numbers and serial nambers of the instruments that were calibrated, intercompared, of compared as required by paragraphs (a) and (b) of this section.
O September 29,1995 35-22
4 i
M.00(c)
M.W(e) j, PART 35 o MEDCAL USE OF BYPRODUCT MATERIAL i
~
\\
the correction factor theI was (d) A heensee shall make full (2) Os.cff error;
/
determined from the cohbration or celibration measurements required by (3) no manan6damaa of b tod6et6on compenson or the apparent correction perspaph (et of this sect 6en in held and the fbeid ladicated by the hght factor that was dekrmined from en accordance alth either h procedures bum looshaies deytee; intercomponeon. the names of the recommended by b Scientific (4)De escuracy of all distence individuals who performed the Committee on Radiet6en Doe 6 metry of meneuring and locaheet6en devices used a
cahbratinn, intercompenson, or the American Association of physicists for enediceluee; j
compenson, and evidence that the in Medicine that are described in (6) N output fw one typical set of f
latercomparison meetmg wee Myelce /A Medicuie end Sioldyy Vol.
operousg conditions measured with the eanctioned by a cohbretion leboretory
- 14. No. 3.1971. pp. 3fHes. or try Teek dosimetrv I l ss.eas(6)erstem deser 1
I or radiolog6c physico center accredsted Group 21 of the Radiation Derapy of this part; and by AAPM.
Committee of h Amortcen Assoc 6etion (6) N ddlerence betwas tlw I of Physiclete in Medictne that are a mesouressent made to pareyeph (b)(6) l 36.448 pas essaremsn measuremoses' R desenbod in MedicalMyesco Vol.10.
6 of this poet 6am and the enuapekd (e) A 16cenwe authorised to uw e a No. 8.1ssa, pp. 741 771. and Vol.11 No.
E output empressed as a percentage of h teletherapy unit for wiedical use shall g 3, ige 4. p. 213. (Both of these references enhelpeted output (l.a., the value l
perform full cohtast6on measuremente have been approved for incorporeuen obtained at last full onlibret6on on each teletherapy unit:
by reference by the Dimeter of the corrockd meesmaueu fw phys 6 cal 4
r j
(1) Before the first medical use of b Federal Regteter. Copeos of the dasy).
unit, and documents are ovellable fut inesect6on et (b) A heensee eheu perfam p
(2) Before medecel bee under the the NRC Library.11545 Rockville Pike.
measuremente requ6 red by pereysph (a) following conditions RockvGle. Maryland 200S2 273& Copies of of this section in scoordance with (1) % henever spot check the documents are also on file et the Ofhce procedures wkbhohed by the measuremente indicate that the orW of Ihe Federal Repstet 1t00 L.$ttnt NW.
teletherapy physicht. Mt individual differs bgtoined at the. a6t full
.nore then 6 rcent frc. a Room 8301 Washington.DC 20404 A need not actually perform the spotcheck output o notice of any change in the meterial will mopuremenu.
catiLration cortected mothematiceily for be pubhshed in the Federal Reg 6 ster )
thplacement of ;he 2
(c) A hcom sheH han h i Follow teletherapy physictet review the results 1
source or followmg reinstallation of the (e) A hoensee shall correct o
t y unit in a new location; mothe'natically the outpute determined y of eech ePot check withinildays W
! eletherebowing any repair of the l
in paresreph (bl(t) of this secilo
. kletherop phyo6ctet shell promptly physical decey for intervale no, n for (tiil ro q
a noufy dw 6 cum in wnt of the 2 teletherapy unit that includes removal of rwuhe of nch spoth benen a the source or maior repair of the eac*ecing one month for cobalt.40 or ela a
1
- componente epociated with the source menths for coelum 137.
" shell keep a copy of each written
}
oposure emmbly; and (f) Full calibration measurv mente notift.:stion for tiuse peers
~
s 1
(3) At intervale not escudmg one required by peregraph (e) of this secuon
- year, and physical decay corrections required (d) A licensee authortsed to sw a (b) To seuefy N requirement of by peregraph (e) of this section must be telethetopy unit for med6 cal use shall peregraph (e) of thie evction. full performed by the licensee's teletherapy perform seley spot. checks of each cabbration meneuremente must include P eicist.
telederapy faenny once in uch l
determination of.
) A licensee shall rotein a record of calender month that asewe proper j
(1)ne output within 23 percent for es celibration for the duret6on of use operat6on of:
the tenge of f6 eld eines and for the of the teletherapy unit source.he (1) Electr6calinterlooke et oech i
distence or range of distences used for 3 mcord must include the date of the teletherapy room entrence; l
medical use g cohbration. the manufacturer's name, (3) Electreal or mechan 6 cal stope (2)De coinc6dence of the redsetion model number, and certal number for instelled for me purpees of halting use I
field and the field indicated by the hght 8 both the teletherep) unit and the source.
of the prunary been of radiation I
been locahe6ag dev6ce:
. the model numbere and serial numbers (restriction of sewee boue6ag engulation (3) De undermit of ilw redieusa
" of the instrumente used to enhbrete the J or elevat6on. eaartage or stand trevel r.id ud ne dependence on the kiemmer unn. isbin met duet. me 3 end spueWes of du bum m off i
l onenteuen of the useful beam; output of the unit over the reage el fleid g memhea60s);
(3) Seem cond6t6en ladicator hehte un i
(4) Timer constancy and kneartty over eines and for the range of destenose used 6
j tlw range of use:
in radiation therapy, e determination of the teletherapy un6t. em the control (6) On off error; and the coinc6dence of the redietton field censole, and in the facinny; (e)ne scenrecy of all4tence and the inold indiceled by the light beam (4) V6ewtes systems:
measurtne and lecellem dev6ces in locahsing dev6ce, en eseosoment of timer (6) Treatment room doore from inside l
medical use.
hneerity and constancy, the calculated and oute6de the treatment room; and (c) A hconese shall.aw the doetmetry on ofi arror, the sotimated occurecy of.
(6) ElectnceUy suieted tmetment l
erstem doecnbod in 6 36.eWoral to uch distence measu6ng or localleeuen roosn doore with the kletherapy urut measum the output for one set of devin. and the signetum of the electrical power turned off.
espesum conditione. De remaining teletherepy physiciet.
(e) A licensee shall errense for prompt redaeuon measuressente required in repair of any system identified in l
peregraph (b)(1) of this sect 6en may be istate ponesseT" "
peregraph (d) of this section that le not made uoms e doelmetry erstem that (e) A booneos authoneed to use operating properly, and shell not use the i
i Lindicates mletive does rates.
teletherapy units for medical use shall teletherapy unit following door interlock j
perform output spot checks on escl.
malfunction until the interlock system teletherapy unit orace in each calender has been repelred.
I month that include determinetion of:
(1) Timer constancy, and timer kneartty over the range of use; g
i I
35 23 Sepestritpor M #95 l
i
,, _ - -. ~, -. _ _ - _ - - -.., -, - -. -. _, _. -,,..
35.634(0 35.M3(b)
PART 35 o MEDK:AL USE OF BYPRODUCT MATERIAL
[f) A hcensee shall retain a record of I H HI hemiseen awvers lor se6ethorapy (c) A bcensee shall retam a record of each spot (hed required by paragraphs tocamus the radiation measurements made (a) and (d) of this section for three years (a)liefore medical use, after each following installation of a source for the The record must include the date of the installation of a teletherapy source, and durat6on of the license. The record must spot check. the manuf acturer's name, efter making any c.hange for which an include the date of the measurements, model numbs.. and senal number 10, E emtidment is required by I 35 806 (a)*
the reason the survey is required. the both the teletherapy urut ar 1 source. the 1, (d), the hcensee shall perform tediation manuf acturer's name, model number manufacturer's name, model number a surveys with a portable radiation and senal number of the teletherapy and senel number of the instrument me'asurement survey instrument unit, the source, and the instrument used used to measure the output of the cahbrated in accordance with I 35 51 of u to measure radiation levels each dose teletherapy unit, en assessment of timer this art to venly that.
y casured around the teletherap g rate it source while in the off position and the n off e
,a t
n t on of h ta s one rne er rom t e tele h ay V comc4dence of the radiation field and source with the source in the off position t average of all measurements, a plan of 2 the field indicated by the h ht beam and the colhmators set for a normal e the areas surroundmg the treatment
~ locebring device, the calcufsted on off treatment field do not etceed to room that were surveyed, the measured
- error, the determmed accuracy of each milkrem per hour and 2 milbrem per dose rate at several points in each area 1 distance measuring or localiation hour, respectively; and exprened in mith.em per hour, the devke, the difference between the
(!) With the teletherapy source in the calculated enaximum quantity of anticipated output and the measured on position with the largest clinically radiation over a period of one week for output, notat6ons 6ndicating the available treatment field and with a each restricted and unrestricted area, operabihty of each entrance door scattering phantom in the primary beam and the signature of the Radiation electrical interlock, each electt: cal or of radiation. that:
Safety Officer, mechanical stop, each beam condition indicator hght, the viewing system and l 35.M3 esodmcation of to6etherapy unit doors. and the signature of the individual who performed the penodic (i) Radiation dose quantities per unit or room before beginning a treetment spot. check.
time in restncted areas are not likely to Program.
cause personnel exposures in excess of (a)If the survey required by I 35.M1
~
l 36.*36 Safe +y checas for Nietherapy g the limits specified in $ 2a1201 of this indicates that an mdividualin an fecemos.
Q; chapter.and g unrestncted area may be esposed to (a) A bcensee shall promptly check all g (til Radiation dose quantities per e levels of radiation greater than those systems heted in l 35 6341d) for proper g unit time in unrestricted areas do not y permitted by $ 20D01 of this chapter.
function afkr each installation of a exceed the limits specified in $ 20D01
- before beginning the treatment program E he hcensee shall:
= teletherapy source and after making any of this chapter.
t g chanse for which an amendment is (1)l'aiher equip the unit with stops or required by 4 35 006 (aHdl.
add additional radiation shielding to
~
a g l,5)!! the results of the checks required emure compliance with 5 2Q001(c) of in paragraph (a) of this section indicate the malfunction of any system specified (b)If the results of the surveys this chaptec in i 35.6Mid), the hcensee shalllock the required in paragtaph (a) of this section control console m the off position and inoicate any radiation dose quantity per g
g g
I ii)t use the unit etcept as may be unit time in excess of the respective necessary to repair, replace or check E limit specified in that paragruph the l 35 M1 assin; and n
u the malfunctionmg system.
E bcensee shalllock the controlin the off g (3) include in the report required by C
E position and not use the unit:
g i 35 M5 the results of the initial survey, (c) A heensee shall retam for three g
(1)I;xce I as rnay be necessary to g a desenption of the modification made years a record of the facihty t. hecks repair, rep ace, or test the teletherapy
- to comply with paragraph (a)(1) of this section, and the results of the second g followmg installation of a source ne unit shieldmg or the treatment room a record must include notatione mdicatmg shieldmg; or
'"NY'
- the operabihty of each entrance door E interlock, each electncal or mechanical
~
al stop, each beam condition indicator (b) As an alternative to the hght, the viewing system, and doors, and r"
requirements set out in paragraph (a) of 2 Until the licensee has re:eived the signature of the Radiation Safety l a s(pe)cific exemption pursuant to this sectior a licensee may request a
. Officer, y $ 20001 of this chaptec license amendment under $ 20001(c) s R
$ of this chapter that authortzes E
E. tyl' ilon levels in unrestricted ansas g
@ greater than those pertnitted by E $ 2QD01(a)of this chaptet Alicenseo L
may not begin the treatment program until the license amendment has been issued.
O september 29,1995 3544
35.645 35.910(b)
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL k
i as saa heperte of totecherapy surveys.
Suhport J-Training and Empettence i neto fresners ser upinha, asumen. and aheshe.teses, and measuremente.
Respulrements escessen eeueen.
A licensa shall mail a copy of the Except as provided in ll 35 970 and records required in ll 35 836. 35 641, 35.971, the hcensee shall require the Wee homenen teemy Omeer.
R authorized user of a 35.643, and the output from the teletherapy source empressed as E* cept as provided in l 35 901 the
% radiopharmaceuticalin i 35100(a) to be toentgens or reds per ;iour at one meter licensee shall require an individual e a ph reician who:
from the source and determined during fulfilhng the responsibthties of the t (a le certified in:
(l? Nuclear medicme by the American the full cabbration required in i 35 632.
g Radinhon Safety Officer as provided in to the appropriate Commission Regional g I 35.32 to be an individual who:
Board of Nuclear Medicine; (a)is certified by:
(2) Diagnostic radiology by the Off'ce listed in 6 30 6 of this chapter g
(1) American Board of Health Physics American Board of Radiology; or within thirty days following completion of the action that initiated the record 3 in Comprehensive Health Physics; requirement.
(2) American Board of Radiology; (3) American Board of Nuclear (3) Diagnostic radiology or radiology i ne47 phyear hepoemen Medicine; by the American Osteopathic Board of Radiology; (a) A heensee shalihave each s
g teletherapy unit fully inspected and 0 (4) Nuclear medicine by the Royal g serviced during teletherapy source (4) American Board of Science in
= College of Physicians and SurEcons of n replacement or at intervals not to Nuclear Medicine; E Canada;or E exceed five years, whichever comes (5) Board of Pharmamutical
$ (5) American Osteopathic Board of Nuclear Medicine in nuclear medicine; Sp(ecialties in Nuclear Pharmacy; E first. to assure proper functioning of the
- 6) American Board of Medical or source esposure mechanism.
g Physics in radiation oncology physics; (b) This inspection and servicing may only be performed by persons
- 17) Royal College of Physicians and specifically licensed to do so by the ll; S cons of Canada in nuclear (b) Has had classroom and laboratory Commission or an Agreement State.
em icine; training in basic radioisotope handling Ic) A licensee shall keep a record of (8) American Osteopathic Doard of techniques applicable to the use of the inspection and servicing for the Radiology; or prepued radiophanneceuticals, and duration of the license.The record must (9) American Osteopathic Board of supervised clinical esperience as contain the inspector's name, the Nuclear Medicine; or gonow,:
(1) 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of classroom and inspector's hcense number, the date of inspection, the manufacturer's name and laboratory training that includes; model number and sertal number for (b) Has had classroom and laboratory (6) Radiation physics and
~
R instrumentation; both the teletherapy unit and source, a training and empenence as follows:
list of components IMpected, a het of (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of clustoom and g gil Radiation protection; r7mponente serviced and the type of laboratory traming that includes:
- (iii) Mathemat6ce pertaining to the use and measurement of radioactivity; service, a list of components replaced.
(1) Radetion physics and (iv) Radiation biology; and and the signature of the inspector.
instrumentation; (v) Radiopharmaceutical chemistry; (ii) Radiation protection; and ltii) Mathematica pertaining to the use and measurement of radioactivity; (2) 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of supervised clinical (iv) Radiation biology; and expenence under the supervision of an (v) Radiopharmaceutical chemistry; authorised user and that includes:
and (2) One year of full time experience as I-*
k res(i) Examining patients or human 1
g a radiation safety technologist at a earch subjects and reviewing their g medicalinstitution under the supervision of theindividualidentified G case histories to determine their g
y as the Radiation Safety Officer on a g suitability for radioisotope diagnosis.
- Commission or Agreement State license e limitations.or contraindications; that authorizes the medical use of byproduct material: or L
(c) Be en authonaed user identified on the beensee's hcense.
(ii) Selecting the suitable
$ radiophannaceuticals and calculating i Etet Tretreg ter esportenood and measunng the dosages; heeseen tetoey omeer.
g An individualidentified as a E'
Radiation Safety Officer on c Commission or Agreement State license i
before October 1.19e8 need not comply L
with the trainmg req trements of I 35 900.
N 35 25 September 29,1995
35.9HMb) 35.920(c)
PART 3G e MED6 CAL USE OF BYPRODUCT MATERIAL r (1) Examining patients or human F (iii) Administering dosages to patients (b) Has had classroom and laboratory s
E or human research subjects and using training in basic radioisotope handling R rnearth subjects and reviewing their
- syringe radiation shields:
techniques applicable to the use of G case histories to determine their E
prepared radiopharmaceuticals.
E suitability for radioisotope diagnosis.
S generatore, and reagent kits, supervised S limitations, car contraindications:
L
- ar' ' P n' ace *ad 'ur*rviad clinical expenence as follows:
b (iv) Collaborating with the authorized (t) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and leboratory training that includes:
user in the interpretation of radioisotope (i) Radiation physics and test tesulto: and (11) Se'eeting the suitable E (ii) Radiation protection;
$ radiopharrraceuticals and calculating instrumentation; g
E M (iii) Mathematics pertaining to the use and measunng the dosages:
e
{
f and measurement of radioactivity:
- (iv) Radiopharmaceutical chemistry; and
{ (v) Patient or human research subject (v) Radiation biology and s
R followup;or (2) 800 hours0.00926 days <br />0.222 hours <br />0.00132 weeks <br />3.044e-4 months <br /> of supervised work E
expenence under the supervision of an E
authortred user that includes:
3 (i) Ordering receiving, and unpacking g (human enearth sutnects and usingiii) Ad tedioactive materials safely and 3 or L
performing the related radiation g syringe radiation shields; surveys; (c) Has successfully completed a sig.
(ii) Calibrating dose calibrators and month training program in nuclest diagnostic instruments and performing medicme se part of a training program checks for proper operation of survey f
that has been approved by the meters.
Accreditation Council for Graduate l-p (iv) Collaborating with the authonted g user in the interpretation of radioisotope Medical Education and that included
~
classroom and laboratory trainmg. work E (iii) Calculating and safely preparing g test resulta; and experience, and supervised clinical
- patient or human researth subject t
$ expenence in all the topics identified in - dosages; g paragraph (b) of this section.
S
[
2 i SiD30 Training for imagbog and
{ (v) Patient or human research subject Glossessaen m Dv) Using adtrinistrative controls to
~
Except as provided in 135 970 or preve.at the misadministration of R followup:or E
33 97., the licensee shall require the byprodud material:
suthorized user of a (v) Using procedures to contain spilled radiopharmaceutical, generator, or byproduct 'natenal safely and using S
reagent kit in 6 35.200(a) to be a g proper decontamination procedures: and l physician who:
g (vil Eluting technetium sem from 1
(a)la certified in:(1) Nuclear medicine by the American a generato. systerda. measuring and testing the eluate for molybdenum-99 (c) Has successfully completed a six.
Board of Nuclear Medicme;
- and alumina contamination, and month training program in nuc'm processing the eluate with reagent kits medicine that has been approved by the
~
to prepare technetium-90m labeled A Accreditation Council for Graduate (2) Diagnostic radiology by the radiopharmaceuticale: and g Medical Education and that included American Board of Radiology; (3) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised chnical
, classroom and laboratory tr. itng, work (3) Diagnostic radiology or radiology experience under the supervision of an experience, and supervised clinical g by the American Osteopathic Board of authortred user that includes:
= experience in all the toples identified in
- Radiology;
[ Paragraph (b) of this section.
E (4) Nuclear medicine by the Royal ll; Collop of Physicians and Surgeons of a Canaca;or (5) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or O
September 29,1995 35 28
M.H0(b)
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL g neae freinene ter therapeutic use of Ineas fremeneteremommentof f (1) Radiology,there utic radiology, or redittion onoclogy y the American E unesened byproduce materie hypertnymisnem.
Except as pmvided in l 35.970, the E Board of Radiology; f
licensee shall require the authortaed S
/
E user of only lodine 131 for the treatment L
a' hyperthyroidism to be a physician R
with special expenence in thyii d
{
i f
diseen who has had classroom a sd Except ae provided in 135 970, the laboratory training in basic radioisotope licensee shall requite the authorized handling techniques applicable to the user of radiophanneceuticals in j 35.300 use oflodine 131 for treating (2) Radiation oncology by the
, to be a physician who:
hyperthyroidism, and supervised clinical American Osteopathic Board of e,.
et nerice as follows:
{ (e)le certified by:
E Radiol
) 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and g3) ghlogy, with specialisation in laboratory training that includes:
radiotherapy, as a British " Follow of the (1) Radiation physics and Faculty of Radiology" or 'Tellow of the instrumentation:
Royal College of Radiology": or r siIing to the use (1)The American Board of Nuclear a e stic C ns nR y 1
y ans Medicine.
and measurement of radioactivity; and
- "d Surgeon (2)The American Board of Radiology (4) Radiation biology; and lb)is in th active practice of g in radiology, therapeutic radiology, or (b) Supervised clinical experience therapeutic radiology, has had under the su rvision of an authorized g radiation oncoloSJicine by the Royal clauroom and laboratory training in (3) Nuclear me user that inc udes the use oflodine 131 redioisotope handling techniques
, College of Physicians and Surgeons of for diagnosis of thyroid function. and the applicable to the therapeutic use of a Canada:or g treatment of hyperthyroidism in to brachytherapy sources, supervised work (4) The American Osteopathic Board M (ndividuals.
experience. and supervised clinical of Radiology after 1984; or hie 934 Training for tweement of thyroie exPertence as follows:
a cereinema (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and g aboratory training that includes:
l Except as provided in i 35.970. the (i) Radiation physics and licensee shall requite the authorized g instrumentation:
A user of only lodme 131 for the treatment g (H) Radisuon protection I
of thyroid carcinoma to be a physician m
(lH) Mathematve naining to the un i
(
(b)llas had clauroom and laboratory with special expenence in thyroid E and measurement opradioactivity; and i
training in basic radioisotope handling disease who has had classroom and fiv) Radiation biology;2) 500 houn of s techniques applicable to the use of laboratory training in basic radioisotope therapeutic radiopharmaceuticals, and handling techniques applicable to the supervised clinical ex[,erience es use of iodine 131 for treating thyroid f'H
" " *C#
on follows:
carcinoma, and supervised clinical est includes:
(1) 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> of classroom and experience as follows:
laboratory training that includes:
(a) ao hours of classroom and (i) Ordering, receiving, and unpacking radioactive raatenals esfely and (i) Radiation physics and laboratory training that includes:
instrumentation:
(1) Radiation physics and performing the related radiation 4 (ill Radiation protection:
Instrumentstion:
surveys:
g (d measurement o rtaining to the use (2) Radiation protection:
(ii) Checking survey metere for propet lii) Mathematica g an adioacuvity; and (3) Mathematica pertaining to the use operation:
(iv) Radiation biology; and and reeasurement of radioactivity; and (til) Preparing. imp nting, and (4) Radiation biology; and mmoving sealed sources:
E (2) Supervised clinical expertence (b) Supervised chnical expedence (iv) Maintaining running inventones under the supervision of an authorized under the su rviolon of an authorized of material on hand; user at a medicalinstitution that user that inc des the use oflodine 131 (v) Using administrative controls to includes:
for the treatment of tnyroid carcinoma
{revent the miesdministration of (i) Use of iodine 131 for diagnosis of in 3 individuals' Yproduct material: and thyroid function and the treatment of (vi) Using emergency procedures to hyperthyroidiam or cardiac dyefunction i as.eae Tremes ter use of broenytnerapy control byproduct material: and in 10 individuela; and seuroes.
(ii) Use of iodine 131 for treatment of Except as provided in i 35.tro, the thyroid carcinoma in 3 individuals.
licensee shall require the authorised user C a brachytherapy source listed in 5 35 400 for therapy to be a physician who:
(a)is certified in:
t 35 27 September 29,1995
%Wc 35,%0(h)
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL a.
f (1) Radiology,there g or redistion oncology b>eutic radiolo (3) Three years of supervised chnical I neto Trainens for use of seeeed y the Amen an cmperience that includes one year in a sources 4r W formal training program approved by the $ F.xcept as provided in l 35 970, the
- Board of Radiology; Residency Review Committee for R licensee shall require the authorized a
Radiology of the Accreditation Council e user of a sealed source in a device listed 3 for Graduate Medical Education or the $ in 6 35.500 to be a physician, dentist, or Committee on postdoctoral Training of '" podiatrist who:
~
the American Osteopathic Association, (a)is certified in:
and an additional two years of chnical experience in therapeutic radiology (2) Radiation oncology by the under the supemston of an authonsed r--
user at a medicalinstitution that l
(1) Radiology, diagnostic radiology.
American Osteopathic Board of includes:
@ tlnrapeutic radiology, or radiation Radiology; logy, with specishration in a Radiology;y the American Board of (1) Examining individuals and g ocewgy b (3) Radio radiotherapy, as a British 'Tellow of the reviewmg their case histones to determine their suitability for 7,; (2) Nuclear medicine by the American Faculty of Radiology" or " Fellow of the brachytherapy treatment. and any
" Board of Nuclear Medicine:
Royal College of Radiology"; or limitations or contraindications; (4) Therapeutic radiology by the (ii) Selecting the proper brachytherapy Canadian Royal College of physicians sources and dose and method of and Surgeons; or administration; (b)is in the active practice of (iii) Calculating the dose; and therapeutic radiology, and has had (3) Diagnostic radiology or radiology classroom and laboratory training in (iv) Post.edministration followup and p feview of case histories in collaboration et by the American Osteopathic Board of basic tedioisotope techniques applicable with the authortred eaer.
M Radiology:or to the use of a sealed source in a E
teletherapy unit, supervised work expenence, and supervised chnical i Et41 Treeneng let ophe. semic use of
[
experience as follows:
y Except as provided in i 3 370, the L
(1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and M licensee shall require the auth 9 cd laboratory training that includes:
(6) Radiation physics and E user of only strontium 90 for ophthalmic r-p (4) Nuclear medicine by the Royal e instrumentation; g radiotherapy to be a physician who is in l College of Physicians and Surgeons of M (ii) Radiation protection:
the active practice of therapeutic
~
radiology or ophthalmology, and has E Canada;or 5 (iii) Mathematics pertaining to the use had elsesroom and laborstory training g and measurement of radioactivity; and (iv) Radiation biology; in basic radioisotope handling h.
(2) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work techniques applicable to the use of n
strontiurn.90 for ophthalmic experience under the supemsion of an radiotherapy, and a period of supervaed {
au'hortred user at a medicalinstitution that includes:
clinical training in ophthalmic (i) Review of the full calibration radiotherapy as follows:
measurements and periodic spot checks:
(a) 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of classroom and (ii Prepanns treatment plans and calcu)leting treatment times; laboratory training that includes:
(b) Has had 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom and (1) Radiation physics and laboratory training in basic radioisotope handling techniques specifically (iii) Using administrative controls to instrumentation; apphcable to the use of the devtce that prevent misadministrations:
(2) Radiation Protection:
includes.
(iv)Impleasenting one ncy (3) Mathematica pertaining to the use and measurement of radioactivity; and (1) Radiation physics, methematica Procedurre to be follow in the event g
ope g,
pertaining to the use and measurement teletherapy unit or console; and and instrumentation; 12 of radioactivity, biology; (v) Checking and using survey meters;
) Supervised clinical training in y (2) Radiation and op thalmic radiotherapy under the M
(3) Radiation protection: and (3)'three years of supervised clinical supervision of an authortred user at a E (4) Training in the use of the device
- 1Perience that includes one year in a medicalinstitution that includes the use E for the uses requested.
of strontium-90 for the ophthalmic formal training program approved by the treatment of five individuals that i neto Training ist tetotherapy.
Residency Review Committee for includes:
Except se provided in i 35.970, the Radiology of the Accreditation Council (1) Examination of isch individual to licensee shall require the authonzed for Creduate Medical Education or the be treated; user of a sealed source listed in I $5.000 Committee on Postdoctoral Training of (2) Calculation of the dose to be in a teletherapy unit to be a physician the American Osteopathic Association and an additional two years of clinical administered; who:
(3) Administration t.,f the dose; and (a)is certified in:
expenence in therapeutic radiology (4) Followup and review of each individual's cass history.
O september 29,1995 35 28
A 35.960(b) 35.980(b)
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL under the Supervision of an authorized i E970 Trehhg for nportenaed (A) Radiation physica and user at a medicalinstitution that sumertwd users.
instrumentation; includes:
Physicians, dentists, or podistrists (B) Radiation protection; identified as authorized use., for the (C) Mathesnatica portaining to the use g rev(t) Examining individuals and iewing their case histories to medical, dental, or podiatric use of and speasuressent of radioecuvity;
( determine theit suitabihty for byproduct matenal on a Commission or (D) Chemistry of byproduct material
- telethe:.py treatment, and any Agreement State hcense issued before for medical use; and Elimitations or contraindications:
April 1.18e87 who perform only those (E) Radiation biology; and (ii) Selecting the pro er dose and how methods of use for which they were (ii) Supervised orportones in a it is to be administere N authortred on that date need not comply nuclear pharmer y involving tia M with the training requirements of following:
Lr Subpart1 (A) Shlpplag, receiving, and (iii) Calculating the teletherapy doses I 34.071 Phyeeseen treinme in a three Pwfwining plated mdisumi auneys; E
(B) Using and performing checks for u
and collaborating with the authorized mene program y user in the review of pauents' or human A physician who, before july 1,19M, P'0Per opwetion of does calibrators, suney anetees, and,if appropriate,
- instrunnente used to snemoun alpha w g reenarch subjects' progrus and began a three month nuclear medicine g
a consideradon of the need to modify training program approved by the
& originally prescribed doses as warranted Accreditation Council for Graduate e betadtung radionuclidw;
- by patients' or human research subjects' Medical Education and has successfully (C) Calculating, assaying, and safely reaction to radiation; and completed the program need not comply Pf' Paring dosages for pauents or human m
u s
with the requirements of ll 35.910 or g
avoid mistakes in the administrauon of
~
byproduct material; (iv) Post administration followup and (E) Using procedums to prevent or review of case histones.
minimita contamination and using j
l g 33.381 Trainens ter to6esherapy phyoietet.
proper decontaminadon procedures; TheI h 11 6 35 072 Recensness of tro6n6ng and M telethere y physibsEo t er individual The training and experience specified (2) Has obtained written certification.
$who.
in this subpart must have been obtained signed by a preceptor authortred (ah ls certified by the American Board within the 7 years preceding the date of nuclear pharmacist, that the above g
' of Radiology in.
application or the individual must have training has teen satisfactorily E
had related continuing education and completed and that the individual has (1) Therapeutic radiological physica; (2) Roentgen rey and samme rey e*Pertence since the required training achieved a level of competency physica; and experience was completed, sufficient to independently operate a (3) X ray and radium physica; or nuclear pharmacy.
(4) Radiological physica; or g
E z
- $ 36.000 Training for an eushortaed nueteer e pharmacest.
The licensee shall require the (b)is certified by the American Board authorized nuclear pharmacist to be a of Medical Phyalce in rediauon pharmacist who:
oncology physics; or (a) Has curant board certl6cetion na (c) Holds a mastern or doctorn
- nucl**r Pharmacist by the Board of Pharmaceutical Specialties, or
~ degree in physica, biophysics, (b)(1) Has com toted 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> in e
{ radiologica! physica, or health physics, structured educa onal program and has completed one year of full time g training in therapeutic radiological consisting of both:
(1) Didactic training in the following R physics and an additional year of full arus:
time work experience under the surervision of a teletherapy physicist at a medical institution that includes the toaka listed in il 35.50, 35.832, 35.634, and 35.M1 of this part.
s 35 29 September 29,1995 1
i 35.999 3!L9ss PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL 5 es tet, frateing ler : ; i _:f nuc4eer Subpart K-Enteroement (b) The regulabons in Part 35 that are
, not issued under subsecuons 161b.1611.
A licensee may apply for and must g or 1010 for the purposes of section 223 isoeive a 11oenee amendment identifying
., are as follows: ll 35.t. 35.2. 35.y. 35 s.
an experienced nuclear pharmacist sa E 35.12,35.15,35.18,35.19,35.5y. 35.100, an euthortmed nuclear pharmacist before 3 35.600.35.901,35.970.35.971.35.990, N
35.991, and 35.999 it allows this individual to work as an (arlbe Conniaanos may obinAn en g authorised nuclear pharmacist. A injuncuos or othn coun wder to eE pharmacist who has completed e P'"ent a v6olation of the provienene structured educauonal p am as
^* A' E""37 A "I I854'
dece 2.
hois rkingin e nuclear pharmacy would qualify as en (2) Title E of the Enwgy expor6enced nuclear pharmacist An Reorgantsadom Ad of 1974, as emended.
exper6enced nucleet pharmacist need not og unnply with the requirements on (3) A,eselmelos er enior toened preceptor statement ($ 31960(b)(2)) and pursuant to those Acts.
1 ts.tw m W eenmeens recentnoes of trainina ($ 31972) to qualify (b) The Comae& semen eney obtale a mg*emente eunne m peM as an authorized nuclest pharmacist court order lor she peremed of a else penalty impo6ed under etction 234 of time if the rules in this part conflict with Atom 6c Emergy Act the licensee's radiation safety program (1) For violauona of-se trientified in its license, and if that (i) Secttooa 53.57.62.63.81.82,101.
license waa epproved by the 103,104,1T. or 100 of the Atome Commission beIore Apnl1,1987 and hae Energ Act of1954. as amended-not been renewed since April 1.1967 the Enugy then the requiremente in the license will E e rfan set o A t(in Any rule, regeletton, or order mrcises its privilege to make minor R
8PP y. Ilowever.if that licensee l
E issued pareeest to the secolone epoolfled in changes in its radiation safsty in parapreyh (bl(1MI) of th6e podiesr.
procedures that are not potentially (iv) Amy earea, seisdesen, w 14eeteuse important to safety under i 35.31 of this of any license teseed ender the eastness chapter, the portion changed must spec $ed in paragraph (hXINI) of this con-ply with the requirements of this
- section, (Il For any e6eletaea for which a Part. At the time of license renewal and licenu may tw r,,ehad sender ascess theresiter, these admendments to this las of the Atomic Energy Act of 1954, se Part shall apply, amended I nee 1 Crknmal penesses.
(a)Sechon 223 of the Atomic Ensesy Act of 1964, as amended, provides for crissanal sanctions for wdlinal violothem of, attempted violation of, or canaparecy to violeta, any reguletaan leased ender sectemas 14th, lett, et 1ste of the Ad.
For pwposes of section 333, all the to6uleeiene la port 38 ase loomed tendet one or more of esctions 19th. Stil, et 1ste, except for the sect 6eas listed te paragraph (b) of this sectica.
e 0
.