ILLINOIS REGISTER 4950
09
ILLINOIS EMERGENCY MANAGEMENT AGENCY
NOTICE OF ADOPTED AMENDMENTS
A) The generator or reagent kit is to be manufactured, labeled and
packaged in accordance with the Federal Food, Drug, and
Cosmetic Act or the Public Health Service Act; or
B) The manufacture and distribution of the generator or reagent kit are
not subject to the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act;
3) The applicant submits information on the radionuclide, chemical and
physical form, packaging, including maximum activity per package, and
shielding provided by the packaging of the radioactive material contained
in the generator or reagent kit;
4) The label affixed to the generator or reagent kit contains information on
the radionuclide, activity and activity assay date; and
5) The label affixed to the generator or reagent kit, or the leaflet or brochure
that accompanies the generator or reagent kit, contains:
A) 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
B) A statement that the generator or reagent kit, as appropriate, is
approved for use by persons licensed by the Agency pursuant to
Section 330.260(a) of this Part and 32 Ill. Adm. Code 335.4010 or
under equivalent licenses of the U.S. Nuclear Regulatory
Commission, an Agreement State or a Licensing State. The labels,
leaflets or brochures required by this subsection (j) are in addition
to the labeling required by the FDA and they may be separate from
or, with the approval of FDA, may be combined with the labeling
required by FDA.
k) Manufacture and Distribution of Sources or Devices Containing Radioactive
Material for Medical Use. An application for a specific license to manufacture
and distribute sources and devices containing radioactive material to persons
licensed pursuant to Section 330.260(a) of this Part for use as a calibration or
