410 IAC 5-3-28 - Schedule of medical use groups
Authority: IC 16-41-35-26; IC 16-41-35-29
Affected: IC 16-41-35
Sec. 28.
Schedule C
Group I. Use of prepared radiopharmaceuticals for certain diagnostic studies involving measurements of uptake, dilution and excretion (does not include uses involving imaging and tumor localizations)
(1) Chromium-51 as sodium chromate or labeled
human serum albumin.
(2) Cobalt-57
as labeled cyanocobalamin.
(3)
Cobalt-58 as labeled cyanocobalamin.
(4) Cobalt-60 as labeled
cyanocobalamin.
(5) Iodine-123 as
sodium iodide.
(6) Iodine-125 as
sodium iodide, iodinated human serum albumin, oleic acid, or sodium
iothalamate.
(7) Iodine-131 as
sodium iodide, iodinated human serum albumin, labeled rose bengal, triolein, or
sodium iodohippurate.
(8) Iron-59
as citrate.
(9) Potassium-42 as
chloride.
(10) Sodium-24 as
chloride.
(11) Technetium-99m as
pertechnetate.
(12) Any radioactive
material in a radiopharmaceutical and for a diagnostic use involving
measurements of uptake, dilution or excretion for which a "Notice of Claimed
Investigational Exemption for a New Drug" (IND) or a "New Drug Application"
(NDA) has been accepted by the Food and Drug Administration (FDA).
Group II. Use of prepared radiopharmaceuticals for diagnostic studies involving imaging and tumor localizations
(1) Chromium-51 as human serum
albumin.
(2) Fluorine-18 in
solution.
(3) Gallium-67 as
citrate.
(4) Gold-198 in colloidal
form.
(5) Indium-113m as
chloride.
(6) Iodine-123 as sodium
iodide.
(7) Iodine-125 as sodium
iodide or fibrinogen.
(8)
Iodine-131 as sodium iodide, iodinated human serum albumin, macroaggregated
iodinated human serum albumin, colloidal (microaggregated) iodinated human
serum albumin, rose bengal, or sodium iodohippurate.
(9) Mercury-197 as chlormerodrin.
(10) Mercury-203 as chlormerodrin.
(11) Selenium-75 as
selenomethionine.
(12) Strontium-85
as nitrate.
(13) Strontium-87m as
chloride.
(14) Technetium-99m as
pertechnetate, sulfur colloid, or macroaggregated human serum
albumin.
(15) Thallium-201 as
chloride.
(16) Ytterbium-169 as
pentatate sodium.
(17) Any
radioactive material in a radiopharmaceutical prepared from a reagent kit
listed in (3) of Group III.
(18)
Any radioactive material in a radiopharmaceutical and for a diagnostic use
involving imaging except those in gaseous forms for which a "Notice of Claimed
Investigational Exemption for a New Drug" (IND) or a "New Drug Application"
(NDA) has been accepted by the Food and Drug Administration (FDA).
Group III. Use of generators and reagent kits for the preparation and use of radiopharmaceuticals containing radioactive material for certain diagnostic uses
(1)
Molybdenum-99/technetium-99m generators for the elution of technetium-99m as
pertechnetate.
(2) Technetium-99m
as pertechnetate for use with reagent kits for preparation and use of
radiopharmaceuticals containing technetium-99m as provided in (3) and (6) of
this group.
(3) Reagent kits for
preparation of technetium-99m labeled:
(i)
sulfur colloid;
(ii) pentatate
sodium;
(iii) human serum albumin
microspheres;
(iv)
polyphosphates;
(v) macroaggregated
human serum albumin;
(vi)
etidronate sodium;
(vii) stannous
pyrophosphate;
(viii) human serum
albumin;
(ix) medronate
sodium;
(x) gluceptate sodium;
and
(xi) oxidronate
sodium.
(4)
Tin-113/indium-113m generators for the elution of indium-113m as
chloride.
(5)
Yttrium-87/strontium-87m generators for the elution of strontium-87m.
(6) Any generator or reagent kit for
preparation and diagnostic use of a radiopharmaceutical containing radioactive
material for which generator or reagent kit a "Notice of Claimed
Investigational Exemption for a New Drug" (IND) has been accepted by the Food
and Drug Administration (FDA).
Group IV. Use of prepared radiopharmaceuticals for certain therapeutic uses that do not normally require hospitalization for purposes of radiation safety
(1)
Iodine-131 as iodide for treatment of hyperthyroidism and cardiac
dysfunction.
(2) Phosphorus-32 as
soluble phosphate for treatment of polycythemia vera, leukemia and bone
metastases.
(3) Phosphorus-32 as
colloidal chromic phosphate for intracavitary treatment of malignant
effusions.
(4) Any radioactive
material in a radiopharmaceutical and for a therapeutic use not normally
requiring hospitalization for purposes of radiation safety for which a "Notice
of Claimed Investigational Exemption for a New Drug" (IND) or a "New Drug
Application" (NDA) has been accepted by the Food and Drug Administration (FDA).
Group V. Use of prepared radiopharmaceuticals for certain therapeutic uses that normally require hospitalization for purposes of radiation safety
(1) Gold-198 as
colloid for intracavitary treatment of malignant effusions.
(2) Iodine-131 as iodide for treatment of
thyroid carcinoma.
(3) Any
radioactive material in a radiopharmaceutical and for a therapeutic use
normally requiring hospitalization for radiation safety reasons for which a
"Notice of Claimed Investigational Exemption for a New Drug" (IND) or a "New
Drug Application" (NDA) has been accepted by the Food and Drug Administration
(FDA).
Group VI. Use of sources and devices containing radioactive material for certain medical uses
(1)
Americium-241 as a sealed source in a device for bone mineral
analysis.
(2) Cesium-137 encased in
needles and applicator cells for topical, interstitial, and intracavitary
treatment of cancer.
(3) Cobalt-60
encased in needles and applicator cells for topical, interstitial, and
intracavitary treatment of cancer.
(4) Gold-198 as seeds for interstitial
treatment of cancer.
(5) Iodine-125
as a sealed source in a device for bone mineral analysis.
(6) Iodine-125 as seeds for interstitial
treatment of cancer.
(7)
Iridium-192 as seeds encased in nylon ribbon for interstitial treatment of
cancer.
(8) Radon-222 as seeds for
topical, interstitial, and intracavitary treatment of cancer.
(9) Radium-226 as a sealed source for
topical, interstitial, and intracavitary treatment of cancer.
(10) Strontium-90 sealed in an applicator for
treatment of superficial eye conditions.
Notes
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