South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part II - LICENSING OF RADIOACTIVE MATERIAL › Section 61-63.II.RHA 2.26 - Schedule D-Groups of Medical Uses of Radioactive Material

Current through Register Vol. 48, No. 6, June 28, 2024
Group I. Use of prepared radiopharmaceuticals for certain
				  diagnostic studies involving measurements of uptake, dilution and excretion. This
				  group does not include uses involving imaging and tumor localizations.
1. Iodine-131 as sodium iodide
				(Na131 I) for measurement of thyroid uptake;
2. Iodine-125 as sodium iodide
				(Na125 I) for measurement of thyroid uptake;
3. Iodine-131 as iodinated human serum albumin
				(IHSA) for determinations of blood and blood plasma volume and for studies of
				cardiovascular function and protein turnover;
4. Iodine-125 as iodinated human serum albumin
				(IHSA) for determination of blood and blood plasma volume and for studies of
				cardiovascular function and protein turnover;
5. Iodine-131 as labeled rose bengal for liver
				function studies;
6. Iodine-125 as
				labeled rose bengal for liver function studies;
7. Iodine-131 as labeled fats or fatty acids for
				fat absorption studies;
8. Iodine-125 as
				labeled fats or fatty acids for fat absorption studies;
9. Iodine-131 as labeled iodopyracet, sodium
				iodohippurate, sodium diatrizoate, diatrizoate methylglucamine, sodium
				diprotrizoate, sodium acetrizoate, or sodium iothalamate for kidney function
				studies;
10. Iodine-125 as labeled
				iodopyracet, sodium iodohippurate, sodium diatrizoate, diatrizoate methylglucamine,
				sodium diprotrizoate, sodium acetrizoate, or sodium iothalamate for kidney function
				studies;
11. Cobalt-57 as labeled
				cyanocobalamin for intestinal absorption studies;
12. Cobalt-58 as labeled cyanocobalamin for
				intestinal absorption studies;
13.
				Cobalt-60 as labeled cyanocobalamin for intestinal absorption studies;
14. Chromium-51 as sodium chromate for
				determination of red blood cell volume and studies of red blood cell survival time
				and gastrointestinal blood loss;
15.
				Chromium-51 as labeled human serum albumin for gastrointestinal protein loss
				studies;
16. Iron-59 as chloride,
				citrate, or sulfate for iron turnover studies;
17. Potassium-42 as chloride for potassium space
				determinations;
18. Sodium-24 as
				chloride for sodium space determinations;
19. Technetium-99m as pertechnetate for blood flow
				studies;
20. Mercury-203 as
				chlormerodrin for kidney function studies;
21. 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) has been accepted by the Food and Drug Administration (FDA) or for
				which an NDA is in effect.
Group II. Use of prepared radiopharmaceuticals for diagnostic
				  studies involving imaging and tumor localizations.
1. Iodine-131 as sodium iodide
				(Na131 I) for thyroid imaging;
2. Iodine-125 as sodium iodide
				(Na125 I) for thyroid imaging;
3. Iodine-125 fibrinogen for detection and
				monitoring of developing deep vein thrombosis.
4. Iodine-131 as iodinated human serum albumin
				(IHSA) for brain tumor localizations and cardiac imaging;
5. Iodine-131 as macroaggregated iodinated human
				serum albumin for lung imaging;
6.
				Iodine-131 as colloidal (microaggregated) iodinated human serum albumin for liver
				imaging;
7. Iodine-131 as labeled rose
				bengal for liver imaging;
8. Iodine-131
				as iodopyracet, sodium iodohippurate, sodium diatrizoate, diatrizoate
				methyglucamine, sodium diprotrizoate or sodium acetrizoate for kidney
				imaging;
9. Iodine-131 as sodium
				iodipamide for cardiac imaging;
10.
				Iodine-131 as iodinated human serum albumin (IHSA) for placenta
				localization;
11. Indium-113m as choride
				for blood pool imaging, including placenta localization.
12. Chromium-51 as sodium chromate for spleen
				imaging;
13. Chromium-51 as labeled
				human serum albumin for placenta localization;
14. Gallium-67 as gallium citrate to demonstrate
				the presence and extent of Hodgken's disease, lymphomas and bronchogenic
				carcinoma.
15. Gold-198 in colloidal
				form for liver imaging;
16. Mercury-197
				as labeled chlormerodrin for kidney and brain imaging;
17. Mercury-203 as labeled chlormerodrin for brain
				imaging;
18. Selenium-75 as labeled
				selenomethionine for pancreas imaging;
19. Strontium-85 as nitrate or chloride for bone
				imaging in patients with suspected or diagnosed cancer;
20. Technetium-99m as pertechnetate for brain
				imaging;
21. Technetium-99m as
				pertechnetate for thyroid imaging;
22.
				Technetium-99m as pertechnetate for salivary gland imaging;
23. Technetium-99m as pertechnetate for blood pool
				imaging, including placenta localization;
24. Technetium-99m as labeled sulfur colloid for
				liver, spleen, and bone marrow imaging;
25. Technetium-99m as labeled macroaggregated
				human serum albumin for lung imaging;
26. Thallium-201 as thallous chloride for
				myocardial perfusion imaging for the diagnosis and localization of myocardial
				infarction.
27. Fluorine-18 in solution
				for bone imaging;
28. Strontium-87m for
				bone imaging;
29. Ytterbium-169 as
				labeled diethylenetriaminepentaacetic acid (DTPA) for cisternography;
30. Iodine-123 a sodium iodide
				(Na123 I) for thyroid imaging;
31. Any radioactive material in a
				radiopharmaceutical prepared from a reagent kit listed in Section (3) of Group
				III;
32. Any radioactive material in a
				radiopharmaceutical and for a diagnostic use involving imaging for which a "Notice
				of Claimed Investigational Exemption for a New Drug" (IND) has been accepted by the
				Food and Drug Administration (FDA) or for which an NDA is in effect.
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 for:
(i) Brain imaging;
(ii) Thyroid imaging;
(iii) Salivary gland imaging;
(iv) Blood pool imaging including placenta
				localization;
(v) Blood flow
				studies;
(vi) Use with reagent kits for
				preparation and use of radiopharmaceuticals containing technetium-99m as provided in
				Sections (3) and (4) of this Group.
2) Technetium-99m as pertechnetate for use with
				reagent kits for preparation and use of radiopharmaceuticals containing
				technetium-99m as provided in Sections (3) and (4) of this Group.
3) Reagent kits for preparation of technetium-99m
				labeled:
(i) Sulfur colloid for liver and spleen
				imaging;
(ii)
				Iron-ascorbate-diethylenetriamine pentaacetic acid complex for kidney
				imaging;
(iii) Diethylenetriamine
				pentaacetic acid (Sn) for kidney imaging and kidney function studies;
(iv) Diethylenetriamine pentaacetic acid (Sn) for
				brain imaging;
(v) Human serum albumin
				microspheres for lung imaging;
(vi)
				Polyphosphates for bone imaging;
(vii)
				Maroaggregated human serum albumin for lung imaging;
(viii) Distannous etidronate complex for bone
				imaging;
(ix) Stannous pyrophosphate for
				bone imaging;
(x) Human serum albumin
				for heart blood pool imaging;
(xi)
				Medronate sodium for bone imaging;
(xii)
				Gluceptate sodium for brain and renal perfusion imaging;
(xiii) Oxidronate sodium for skeletal
				imaging;
(xiv) Disofenin for
				hepatobiliary imaging;
(xv) Succimer
				(DMSA) for renal imaging;
(xvi)
				Pentetate as an aerosol for lung function studies;
(xvii) Sulphur colloid for gastroesophageal
				imaging;
(xviii) Sulphur colloid for Le
				Veen shunt imaging;
(xix) Pertechnetate
				for Le Veen shunt imaging;
(xx)
				Macroaggregated human serum albumin for Le Veen shunt imaging;
(xxi) Pertechnetate for cystography.
(xxii) Pertechnetate for
				dacryocystography.
4)
				Tin-113/Indium-113m generators for the elution of Indium-113m as chloride for:
(i) Blood pool imaging including placenta
				localization.
5)
				Yttrium-87/Strontium-87m generators for the elution of Strontium-87m for bone
				imaging.
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) or for which an NDA is in effect.
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 phosphorus 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) has been accepted by the Food and Drug
				Administration (FDA) or for which an NDA is in effect.
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) has been accepted by the Food and
				Drug Administration (FDA) or for which an NDA is in effect.
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. Iridium-192 as seeds encased in nylon ribbon
				for interstitial treatment of cancer;
7.
				Strontium-90 sealed in an applicator for treatment of superficial eye
				conditions.
8. Iodine-125 as seeds for
				interstitial treatment of cancer.
9.
				Radium-226 encased in needles and applicator cells for topical, interstitial, and
				intracavitary treatment of cancer.
10.
				Radon-222 as seeds for interstitial treatment of cancer.