Current through Register Vol. 43, No. 12, March 20,
2024
Each application for a specific license to manufacture and
distribute generators or reagent kits containing radioactive material for
preparation of radiopharmaceuticals by persons licensed as specified in
K.A.R.
28-35-181d for the uses listed in group III,
shall meet the requirements of subsections (a), (b), (c), and (d).
(a) Each applicant shall meet the general
requirements specified in K.A.R. 28-35-180a.
(b) Each applicant shall submit documentation
of one of the following:
(1) The generator or
reagent kit is subject to the federal food, drug and cosmetic act or the public
health service act and will be manufactured, labeled, and packaged in
accordance with a new drug application (NDA) approved by the food and drug
administration (FDA), a biologic product license issued by FDA, or a "notice of
claimed investigational exemption for a new drug" (IND) accepted by FDA.
(2) The manufacture and
distribution of the generator or reagent kit is not subject to the federal
food, drug, and cosmetic act and the public health service act.
(c) Each applicant shall submit
information on the following:
(1) The
radionuclide;
(2) the chemical and
physical form of the material;
(3)
packaging, including maximum activity per package; and
(4) shielding provided by the packaging of
the radioactive material contained in the generator or reagent kit.
(d) The label affixed to the
generator or reagent kit shall contain information on the radionuclide,
quantity, and date of assay.
(e)
The label affixed to the generator or reagent kit, or the leaflet or brochure
that accompanies the generator or reagent kit, shall contain the following:
(1) Adequate information, from a radiation
safety standpoint, on the procedures to be followed and the equipment and
shielding to be used in eluting the generator or processing radioactive
material with the reagent kit; and
(2) a statement that "this generator or
reagent kit, as appropriate, is approved for use by persons licensed by the
department according to K.A.R. 28-35-181d for group III uses, or under
equivalent licenses of the United States nuclear regulatory commission or
another agreement state." The labels, leaflets, or brochures required by this
paragraph shall be in addition to the labeling required by the FDA. The labels,
leaflets, or brochures may be separate from FDA labeling, or with the approval
of FDA, the labeling may be combined with the labeling required by the FDA.
