Current through Register No. 40, October 3, 2024
(a) A licensee shall not administer to humans
a radiopharmaceutical that contains:
(1) More
than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m
(0.15 microcurie of molybdenum-99 per millicurie of technetium-99m);
or
(2) More than 0.02 kilobecquerel
of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02
microcurie of strontium-82 per millicurie of rubidium-82 chloride); or more
than 0.2 kilobecquerel of strontium-85 per megabequerel of rubidium-82 chloride
injection (0.2 microcurie of strontium-85 per millicurie of
rubidium-82).
(b) A
licensee that uses molybdenum-99/technetium-99m generators for preparing a
technetium-99m radiopharmaceutical shall measure the molybdenum-99
concentration in each eluate from a generator to demonstrate compliance with
He-P
4035.32(a).
(c) A licensee that uses a
strontium-82/rubidium-82 generator for preparing a rubidium-82
radiopharmaceutical shall, before the first patient use of the day, measure the
concentration of radionuclides strontium-82 and strontium-85 to demonstrate
compliance with He-P
4035.32(a).
(d) If a licensee is required to measure the
molybdenum-99 concentration or strontium-82 and strontium-85 concentrations,
the licensee shall retain a record of each measurement. A licensee shall
maintain the record for 3 years. The record shall include:
(1) For each measured elution of
technetium-99m, the ratio of the measures expressed as kilobecquerel of
molybdenum-99 per megabecquerel of technetium-99m (or microcuries of molybdenum
per millicurie of technetium), the time and date of the measurement, and the
name of the individual who made the measurement; or
(2) For each measured elution of rubidium-82,
the ratio of the measures expressed as kilobecquerel of strontium-82 per
megabecquerel of rubidium-82 (or microcuries of strontium-82 per millicurie of
rubidium) and kilobecquerel of strontium-85 per megabecquerel of rubidium-82
(or microcuries of strontium-85 per millicurie of rubidium), the time and date
of the measurement, and the name of the individual who made the
measurement.
(e) The
licensee shall report any measurement that exceeds the limits in
He-P
4035.32(a) at the time of generator
elution, in accordance with the following:
(1) The licensee shall notify by telephone
DHHS/RHS and the distributor of the generator within 7 calendar days after
discovery that an eluate exceeded the permissible concentration listed in
He-P
4035.32(a) at the time of generator
elution. The telephone report to DHHS/RHS shall include the manufacturer, model
number, and serial number (or lot number) of the generator; the results of the
measurement; the date of the measurement; whether dosages were administered to
patients or human research subjects, when the distributor was notified, and the
action taken.
(2) By an appropriate
method listed in He-P 4001.08, the licensee shall
submit a written report to DHHS/RHS within 30 calendar days after discovery of
an eluate exceeding the permissible concentration at the time of generator
elution. The written report shall include the action taken by the licensee; the
patient dose assessment; the methodology used to make this dose assessment if
the eluate was administered to patients or human research subjects; and the
probable cause and an assessment of failure in the licensee's equipment,
procedures or training that contributed to the excessive readings if an error
occurred in the licensee's breakthrough determination; and the information in
the telephone report as required by
He-P
4035.32(e)(1).
(f) Licensees who use strontium-90 for
ophthalmic treatments shall ensure that certain activities as specified in
He-P
4035.32(g) and (h) are performed by
either:
(1) An authorized medical physicist;
or
(2) An individual who is
identified as an ophthalmic physicist on a specific medical use license issued
by DHHS\RHS, an agreement state, or the Nuclear Regulatory Commission; permit
issued by DHHS/RHS, an agreement state, or a Nuclear Regulatory Commission
broad scope medical use licensee; medical use permit issued by a Nuclear
Regulatory Commission master material license; or permit issued by a Nuclear
Regulatory Commission master material licensee broad scope medical use
permittee; and
a. Holds a master's or doctor's
degree in physics, medical physics, other physical sciences, engineering, or
applied mathematics from an accredited college or university; and
b. Has successfully completed 1 year of
full-time training in medical physics and an additional year of full-time work
experience under the supervision of a medical physicist; and has documented
training in:
1. The creation, modification,
and completion of written directives;
2. Procedures for administrations requiring a
written directive; and
3.
Performing the calibration measurements of brachytherapy sources as detailed in
He-P
4035.46.
(g) The individuals who are identified in
He-P
4035.32(f) shall calculate the
activity of each strontium-90 source that is used to determine the treatment
times for ophthalmic treatments. The decay calculation shall be based on the
activity determined under
He-P
4035.46.
(h) The individuals who are identified in
He-P
4035.32(f) shall assist the licensee
in developing, implementing, and maintaining written procedures to provide high
confidence that the administration is in accordance with the written
directives. These procedures shall include the frequencies that the individual
meeting the requirements in
He-P
4035.32(f) will:
(1) Observe treatments;
(2) Review the treatment
methodology;
(3) Calculate
treatment time for the prescribed dose; and
(4) Review records to verify that the
administrations were in accordance with the written directives.
(i) A licensee shall retain a
record of the activity of each strontium-90 source required by
He-P
4035.32(f) and (g) for the life of
the The record shall include:
(1) The date
and initial activity of the source as determined under
He-P
4035.46; and
(2) For each decay calculation, the date and
the source activity as determined under
He-P
4035.32(g).
(See Revision Note at part heading for He-P 4035) #6942,
eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07
New. #8959, eff
8-7-07
