[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.2]

[Page 552-555]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
                     Subpart A--General Information
 
Sec. 35.2  Definitions.

    Address of use means the building or buildings that are identified 
on the license and where byproduct material may be received, used, or 
stored.
    Agreement State means any State with which the Commission or the 
Atomic Energy Commission has entered into an effective agreement under 
subsection 274b of the Atomic Energy Act of 1954, as amended.
    ALARA (as low as reasonably achievable) means making every 
reasonable effort to maintain exposures to radiation as far below the 
dose limits as is practical:
    (1) Consistent with the purpose for which the licensed activity 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 utilization of nuclear energy in the public 
interest.
    Area of use means a portion of an address of use that has been set 
aside for the purpose of receiving, using, or storing byproduct 
material.
    Authorized nuclear pharmacist means a pharmacist who is:
    (1) Board certified as a nuclear pharmacist by the Board of 
Pharmaceutical Specialties;
    (2) Identified as an authorized nuclear pharmacist on a Commission 
or Agreement State license that authorizes the use of byproduct material 
in the practice of nuclear pharmacy; or
    (3) Identified as an authorized nuclear pharmacist on a permit 
issued by a Commission or Agreement State specific licensee of broad 
scope that is authorized to permit the use of byproduct material in the 
practice of nuclear pharmacy.
    Authorized user means a physician, dentist, or podiatrist who is:
    (1) Board certified by at least one of the boards listed in 
Paragraph (a) of Secs. 35.910, 35.920, 35.930, 35.940, 35.950, or 
35.960;
    (2) Identified as an authorized user on a Commission or Agreement 
State license that authorizes the medical use of byproduct material; or
    (3) Identified as an authorized user on a permit issued by a 
Commission or Agreement State specific licensee of broad scope that is 
authorized to permit the medical use of byproduct material.
    Brachytherapy source means an individual sealed source or a 
manufacturer-assembled source train that is not designed to be 
disassembled by the user.
    Dedicated check source means a radioactive source that is used to 
assure the constant operation of a radiation detection or measurement 
device over several months or years.
    Dental use means the intentional external administration of the 
radiation from byproduct material to human beings in the practice of 
dentistry in accordance with a license issued by a State or Territory of 
the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico.
    Dentist means an individual licensed by a State or Territory of the 
United States, the District of Columbia, or the Commonwealth of Puerto 
Rico to practice dentistry.
    Diagnostic clinical procedures manual means a collection of written 
procedures that describes each method (and other instructions and 
precautions) by which the licensee performs diagnostic

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clinical procedures; where each diagnostic clinical procedure has been 
approved by the authorized user and includes the radiopharmaceutical, 
dosage, and route of administration.
    Management means the chief executive officer or that person's 
delegate or delegates.
    Medical Institution means an organization in which several medical 
disciplines are practiced.
    Medical use means the intentional internal or external 
administration of byproduct material or the radiation therefrom to 
patients or human research subjects under the supervision of an 
authorized user.
    Ministerial change means a change that is made, after ascertaining 
the applicable requirements, by persons in authority in conformance with 
the requirements and without making a discretionary judgment about 
whether those requirements should apply in the case at hand.
    Misadministration means the administration of:
    (1) A radiopharmaceutical dosage greater than 30 microcuries of 
either sodium iodide I-125 or I-131:
    (i) Involving the wrong individual, or wrong radiopharmaceutical; or
    (ii) When both the administered dosage differs from the prescribed 
dosage by more than 20 percent of the prescribed dosage and the 
difference between the administered dosage and prescribed dosage exceeds 
30 microcuries.
    (2) A therapeutic radiopharmaceutical dosage, other than sodium 
iodide I-125 or I-131:
    (i) Involving the wrong individual, wrong radiopharmaceutical, or 
wrong route of administration; or
    (ii) When the administered dosage differs from the prescribed dosage 
by more than 20 percent of the prescribed dosage.
    (3) A gamma stereotactic radiosurgery radiation dose:
    (i) Involving the wrong individual, or wrong treatment site; or
    (ii) When the calculated total administered dose differs from the 
total prescribed dose by more than 10 percent of the total prescribed 
dose.
    (4) A teletherapy radiation dose:
    (i) Involving the wrong individual, wrong mode of treatment, or 
wrong treatment site;
    (ii) When the treatment consists of three or fewer fractions and the 
calculated total administered dose differs from the total prescribed 
dose by more than 10 percent of the total prescribed dose;
    (iii) When the calculated weekly administered dose exceeds the 
weekly prescribed dose by 30 percent or more of the weekly prescribed 
dose; or
    (iv) When the calculated total administered dose differs from the 
total prescribed dose by more than 20 percent of the total prescribed 
dose.
    (5) A brachytherapy radiation dose:
    (i) Involving the wrong individual, wrong radioisotope, or wrong 
treatment site (excluding, for permanent implants, seeds that were 
implanted in the correct site but migrated outside the treatment site);
    (ii) Involving a sealed source that is leaking;
    (iii) When, for a temporary implant, one or more sealed sources are 
not removed upon completion of the procedure; or
    (iv) When the calculated administered dose differs from the 
prescribed dose by more than 20 percent of the prescribed dose.
    (6) A diagnostic radiopharmaceutical dosage, other than quantities 
greater than 30 microcuries of either sodium iodide I-125 or I-131, 
both:
    (i) Involving the wrong individual, wrong radiopharmaceutical, wrong 
route of administration, or when the administered dosage differs from 
the prescribed dosage; and
    (ii) When the dose to the individual exceeds 5 rems effective dose 
equivalent or 50 rems dose equivalent to any individual organ.
    Mobile nuclear medicine service means the transportation and medical 
use of byproduct material.
    Output means the exposure rate, dose rate, or a quantity related in 
a known manner to these rates from a teletherapy unit for a specified 
set of exposure conditions.
    Pharmacist means an individual licensed by a State or Territory of 
the

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United States, the District of Columbia, or the Commonwealth of Puerto 
Rico to practice pharmacy.
    Physician means a medical doctor or doctor of osteopathy licensed by 
a State or Territory of the United States, the District of Columbia, or 
the Commonwealth of Puerto Rico to prescribe drugs in the practice of 
medicine.
    Podiatric use means the intentional external administration of the 
radiation from byproduct material to human beings in the practice of 
podiatry in accordance with a license issued by a State or Territory of 
the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico.
    Podiatrist means an individual licensed by a State or Territory of 
the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico to practice podiatry.
    Prescribed dosage means the quantity of radiopharmaceutical activity 
as documented:
    (1) In a written directive; or
    (2) Either in the diagnostic clinical procedures manual or in any 
appropriate record in accordance with the directions of the authorized 
user for diagnostic procedures.
    Prescribed dose means:
    (1) For gamma stereotactic radiosurgery, the total dose as 
documented in the written directive;
    (2) For teletherapy, the total dose and dose per fraction as 
documented in the written directive; or
    (3) For brachytherapy, either the total source strength and exposure 
time or the total dose, as documented in the written directive.
    Radiation Safety Officer means the individual identified as the 
Radiation Safety Officer on a Commission license.
    Recordable event means the administration of:
    (1) A radiopharmaceutical or radiation without a written directive 
where a written directive is required;
    (2) A radiopharmaceutical or radiation where a written directive is 
required without daily recording of each administered 
radiopharmaceutical dosage or radiation dose in the appropriate record;
    (3) A radiopharmaceutical dosage greater than 30 microcuries of 
either sodium iodide I-125 or I-131 when both:
    (i) The administered dosage differs from the prescribed dosage by 
more than 10 percent of the prescribed dosage, and
    (ii) The difference between the administered dosage and prescribed 
dosage exceeds 15 microcuries;
    (4) A therapeutic radiopharmaceutical dosage, other than sodium 
iodide I-125 or I-131, when the administered dosage differs from the 
prescribed dosage by more than 10 percent of the prescribed dosage;
    (5) A teletherapy radiation dose when the calculated weekly 
administered dose exceeds the weekly prescribed dose by 15 percent or 
more of the weekly prescribed dose; or
    (6) A brachytherapy radiation dose when the calculated administered 
dose differs from the prescribed dose by more than 10 percent of the 
prescribed dose.
    Sealed source means any byproduct material that is encased in a 
capsule designed to prevent leakage or escape of the byproduct material.
    Teletherapy physicist means the individual identified as the 
teletherapy physicist on a Commission license.
    Written directive means an order in writing for a specific patient 
or human research subject, dated and signed by an authorized user prior 
to the administration of a radiopharmaceutical or radiation, except as 
specified in paragraph (6) of this definition, containing the following 
information:
    (1) For any administration of quantities greater than 30 microcuries 
of either sodium iodide I-125 or 1-131: the dosage;
    (2) For a therapeutic administration of a radiopharmaceutical other 
than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage, and 
route of administration;
    (3) For gamma stereotactic radiosurgery: target coordinates, 
collimator size, plug pattern, and total dose;
    (4) For teletherapy: the total dose, dose per fraction, treatment 
site, and overall treatment period;

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    (5) For high-dose-rate remote afterloading brachytherapy: the 
radioisotope, treatment site, and total dose; or
    (6) For all other brachytherapy:
    (i) Prior to implantation: the radioisotope, number of sources, and 
source strengths; and
    (ii) After implantation but prior to completion of the procedure: 
the radioisotope, treatment site, and total source strength and exposure 
time (or, equivalently, the total dose).

[51 FR 36951, Oct. 16, 1986, as amended at 56 FR 34120, July 25, 1991; 
59 FR 61781, Dec. 2, 1994; 60 FR 48626, Sept. 20, 1995]