| (ii) each administration is in accordance with the
written directive.
(B) The procedures required by subparagraph (A) of
this paragraph shall, at a minimum, address the following items that
are applicable for the licensee's use of radioactive material:
(i) verifying the identity of the patient or human
research subject;
(ii) verifying that the administration is in accordance
with the treatment plan, if applicable, and the written directive;
(iii) checking both manual and computer-generated dose
calculations; and
(iv) verifying that any computer-generated dose calculations
are correctly transferred into the consoles of therapeutic medical
units authorized by subsection (dd) of this section.
(C) A licensee shall maintain a copy of the procedures
required by subparagraph (A) of this paragraph in accordance with
subsection (www) of this section.
(u) Suppliers for sealed sources or devices for medical
use. A licensee may only use the following for medical use:
(1) sealed sources or devices manufactured, labeled,
packaged, and distributed in accordance with a license issued by the
agency, the NRC, or an agreement state;
(2) sealed sources or devices non-commercially transferred
from an NRC or agreement state medical use licensee; or
(3) teletherapy sources manufactured and distributed
in accordance with a license issued by the agency, the NRC, or an
agreement state.
(v) Possession, use, and calibration of dose calibrators
to measure the activity of unsealed radioactive material.
(1) For direct measurements performed in accordance
with subsection (x) of this section, the licensee shall possess and
use instrumentation to measure the activity of unsealed radioactive
material before it is administered to each patient or human research
subject.
(2) The licensee shall calibrate the instrumentation
specified in paragraph (1) of this subsection in accordance with nationally
recognized standards or the manufacturer's instructions.
(3) The calibration required by paragraph (2) of this
subsection shall include tests for constancy, accuracy, linearity,
and geometry dependence, as appropriate to demonstrate proper operation
of the instrument. The tests for constancy, accuracy, linearity, and
geometry dependence shall be conducted at the following intervals:
(A) constancy at least once each day prior to assay
of patient dosages;
(B) linearity at installation, repair, relocation,
and at least quarterly thereafter;
(C) geometry dependence at installation; and
(D) accuracy at installation and at least annually
thereafter.
(4) The licensee shall maintain a record of each instrument
calibration in accordance with subsection (www) of this section. The
record shall include the following:
(A) model and serial number of the instrument and calibration
sources;
(B) complete date of the calibration including the
month, day and year;
(C) results of the calibration; and
(D) name of the individual who performed the calibration.
(w) Calibration of survey instruments. A licensee shall
calibrate the survey instruments used to show compliance with this
subsection and with §289.202 of this title before first use,
annually, and following a repair that affects the calibration. A licensee
shall:
(1) calibrate all scales with readings up to 10 millisieverts
(mSv) (1000 millirem (mrem)) per hour with a radiation source;
(2) calibrate two separated readings on each scale
or decade that will be used to show compliance;
(3) conspicuously note on the instrument the complete
date of the calibration including the month, day, and year;
(4) not use survey instruments if the difference between
the indicated exposure rate and the calculated exposure rate is more
than 20%; and
(5) maintain a record of each survey instrument calibration
in accordance with subsection (www) of this section.
(x) Determination of dosages of unsealed radioactive
material for medical use.
(1) Before medical use, the licensee shall determine
and record the activity of each dosage.
(2) For a unit dosage, this determination shall be
made by:
(A) direct measurement of radioactivity; or
(B) a decay correction, based on the activity or activity
concentration determined by the following:
(i) a manufacturer or preparer licensed in accordance
with §289.252(r) of this title, or under an equivalent NRC or
agreement state license;
(ii) an NRC or agreement state licensee for use in
research in accordance with a Radioactive Drug Research Committee-approved
protocol or an Investigational New Drug (IND) protocol accepted by
the FDA; or
(iii) a positron emission tomography (PET) radioactive
drug producer licensed in accordance with §289.252(kk) of this
title or equivalent NRC or agreement state requirements.
(3) For other than unit dosages, this determination
shall be made by:
(A) direct measurement of radioactivity;
(B) combination of measurement of radioactivity and
mathematical calculations; or
(C) combination of volumetric measurements and mathematical
calculations, based on the measurement made by:
(i) a manufacturer or preparer licensed in accordance
with §289.252(r) of this title, or under an equivalent NRC or
agreement state license; or
(ii) a PET radioactive drug producer licensed in accordance
with §289.252(kk) of this title or equivalent NRC or agreement
state requirements.
(4) Unless otherwise directed by the authorized user,
a licensee shall not use a dosage if the dosage does not fall within
the prescribed dosage range or if the dosage differs from the prescribed
dosage by more than 20%.
(5) A licensee restricted to only unit doses prepared
in accordance with §289.252(r) of this title need not comply
with paragraph (2) of this subsection, unless the administration time
of the unit dose deviates from the nuclear pharmacy's pre-calibrated
time by 15 minutes or more.
(6) A licensee shall maintain a record of the dosage
determination required by this subsection in accordance with subsection
(www) of this section for inspection by the agency. The record shall
contain the following:
(A) the radiopharmaceutical;
(B) patient's or human research subject's name or identification
number if one has been assigned;
(C) prescribed dosage;
(D) determined dosage or a notation that the total
activity is less than 30 µCi (1.1 MBq);
(E) the date and time of the dosage determination;
and
(F) the name of the individual who determined the dosage.
(y) Authorization for calibration and reference sources.
Any licensee authorized by subsections (n), (o), (p) or (q) of this
section for medical use of radioactive material may receive, possess,
and use the following radioactive material for check, calibration,
and reference use:
(1) sealed sources manufactured and distributed in
accordance with a license issued by the agency, the NRC, or another
agreement state and that do not exceed 30 millicuries (mCi) (1.11
gigabecquerel (GBq)) each;
(2) sealed sources redistributed by a licensee authorized
to redistribute the sealed sources manufactured and distributed in
accordance with a license issued by the agency, the NRC, or another
agreement state and that do not exceed 30 mCi (1.11GBq) each, provided
the redistributed sealed sources are in the original packaging and
shielding and are accompanied by the manufacturer's approved instructions;
(3) any radioactive material with a half-life not longer
than 120 days in individual amounts not to exceed 15 mCi (0.56 GBq);
(4) any radioactive material with a half-life longer
than 120 days in individual amounts not to exceed the smaller of 200 µCi
(7.4 MBq) or 1000 times the quantities in §289.202(ggg)(3) of
this title; and
(5) technetium-99m in amounts as needed.
(z) Requirements for possession of sealed sources and
brachytherapy sealed sources. A licensee in possession of any sealed
source or brachytherapy source shall:
(1) follow the radiation safety and handling instructions
supplied by the manufacturer and the leakage test requirements in
accordance with §289.201(g) of this title and reporting requirements
in §289.202(bbb) of this title; and
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