Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 5 - RADIOLOGICAL HEALTH › Rule 3 - Licensing of Radioactive Material › Section 3-28 - Schedule of medical use groups

Current through July 10, 2024
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.