Section 410IAC5-3-28. Schedule of medical use groups

 

                                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.

(Indiana State Department of Health; Rule HRH-2,PT C,Schedule C; filed May 26, 1978, 3:30 pm: 1 IR 170; filed Feb 29, 1984, 10:10 am: 7 IR 885; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA)