Current through Register Vol. 48, No. 9, September 27, 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.
