37.14.552    TRANSPORTATION: PREPARATION OF MATERIAL

(1) For the purposes of this rule, a licensee who transports his own licensed material as a private carrier is considered to have delivered such material to a carrier for transport.

(2) No licensee shall deliver any radioactive material to a carrier for transport, unless:

(a) the licensee complies with the applicable requirements of the regulations, appropriate to the mode of transport, of the US department of transportation insofar as such regulations relate to the packaging of radioactive material, and to the monitoring, marking and labeling of those packages;

(b) the licensee has established procedures for opening and closing packages in which radioactive material is transported to provide safety and to assure that, prior to the delivery to a carrier for transport, each package is properly closed for transport; and

(c) prior to delivery of a package to a carrier for transport, the licensee shall assure that any special instructions needed to safely open the package are sent to or have been available to the consignee.

(3) Section (2) of this rule shall not apply to the transportation of licensed material, or to the delivery of licensed material to a carrier for transport, where such transportation is subject to the regulations of the US department of transportation or the US postal service.

SCHEDULE A

 

EXEMPT CONCENTRATIONS

 

Element (atomic number)	Isotope	Column I Gas Concentration µCi/ml1	Column II Liquid & Solid Concentration µCi/ml2
Antimony (51)     Argon (18)	Sb-122 Sb-124 Sb-125 Ar-37 Ar-41	1x10-3 4x10-7	3x10-4 2x10-4 1x10-3
Arsenic (33)	As-73 As-74 As-76 As-77		5x10-3 5x10-4 2x10-4 8x10-4
Barium (56)   Beryllium (4) Bismuth (83)	Ba-131 Ba-140 Be-7 Bi-206		2x10-3 3x10-4 2x10-2 4x10-4
Bromine (35) Cadmium (48)	Br-82 Cd-109 Cd-115m Cd-115	4x10-7	3x10-3 2x10-3 3x10-4 3x10-4
Calcium (20)   Carbon (6) Cerium (58)	Ca-45 Ca-47 C-14 Ce-141 Ce-143 Ce-144	1x10-6	9x10-5 5x10-4 8x10-3 9x10-4 4x10-4 1x10-4
Cesium (55)     Chlorine (17)	Cs-131 Cs-134m Cs-134 Cl-38	9x10-7	2x10-2 6x10-2 9x10-5 4x10-3
Chromium (24) Cobalt (27)     Copper (29) Dysprosium (66)	Cr-51 Co-57 Co-58 Co-60 Cu-64 Dy-165 Dy-166		2x10-2 5x10-3 1x10-3 5x10-4 3x10-3 4x10-3 4x10-4

 

__________

 

¹ Values are given in Column I only for those materials normally used as gases.

² µ C1/gm for solids.

Element (atomic number)	Isotope	Column I Gas Concentration µCi/ml1	Column II Liquid & Solid Concentration µCi/ml2
Erbium (68)   Europium (63)	Er-169 Er-171 Eu-152 Eu-155	6x10-4	9x10-4 1x10-3 (Tr=9.2 h) 2x10-3
Fluorine (9) Gadolinium (64)	F-18 Gd-153 Gd-159	2x10-6	8x10-3 2x10-3 8x10-4
Gallium (31) Germanium (32) Gold (79)	Ga-72 Ge-71   Au-196 Au-198 Au-199		4x10-4 2x10-2   2x10-3 5x10-4 2x10-3
Hafnium (72) Hydrogen (1) Indium (49)	Hf-181 H-3 In-113m In-114m	5x10-6	7x10-4 3x10-2 1x10-2 2x10-4
Iodine (53)	I-126 I-131 I-132 I-133 I-134	3x10-9 3x10-9 8x10-8 1x10-8 2x10-7	2x10-5 2x10-5 6x10-4 7x10-5 1x10-3
Iridium (77)     Iron (26)	Ir-190 Ir-192 Ir-194 Fe-55 Fe-59		2x10-3 4x10-4 3x10-4 8x10-3 6x10-4
Krypton (36)   Lanthanum (57) Lead (82) Lutetium (71)	Kr-85m Kr-85 La-140 Pb-203 Lu-177	1x10-6 3x10-6	2x10-4 4x10-3 1x10-3
Manganese (25)   Mercury (80)     Molybdenum (42)	Mn-52 Mn-54 Mn-56 1x10-3 Hg-197m Hg-197 Hg-203 Mo-99		3x10-4 1x10-3 1x10-3 2x10-3 3x10-3 2x10-4 2x10-3

 

__________

 

¹ Values are given in Column I only for those materials normally used as gases.

² µ C1/gm for solids.

Element (atomic number)	Isotope	Column I Gas Concentration µCi/ml1	Column II Liquid & Solid Concentration µCi/ml2
Neodymium (60)	Nd-147 Nd-149		6x10-4 3x10-3
Nickel (28)	Ni-65		1x10-3
Niobium (Columbium) (41)	Nb-95 Nb-97		1x10-3 9x10-3
Osmium (76)	Os-185 Os-191m Os-191 Os-193		7x10-4 3x10-2 2x10-3 6x10-4
Palladium (46)	Pd-103 Pd-109		3x10-3 9x10-4
Phosphorus (15)	P-32		2x10-4
Platinum (78)	Pt-191 Pt-193m Pt-197m Pt-197		1x10-3 1x10-2 1x10-2 1x10-3
Potassium (19)	K-42		3x10-3
Praseodymium (59)	Pr-142 Pr-143		3x10-4 5x10-4
Promethium (61)	Pm-147 Pm-149		2x10-3 4x10-4
Rhenium (75)	Re-183 Re-186 Re-188		6x10-3 9x10-4 6x10-4
Rhodium (45)	Rh-103m Rh-105		1x10-1 1x10-3
Rubidium (37)	Rb-86		7x10-4
Ruthenium (44)	Ru-97 Ru-103 Ru-105 Ru-106		4x10-3 8x10-4 1x10-3 1x10-4
Samarium (62)	Sm-153		8x10-4
Scandium (21)	Sc-46 Sc-47 Sc-48		4x10-4 9x10-4 3x10-4
Selenium (34)	Se-75		3x10-3
Silicon (14)	Si-31		9x10-3

 

__________

 

¹ Values are given in Column I only for those materials

normally used as gases.

² µ C1/gm for solids.

Element (atomic number)	Isotope	Column I Gas Concentration µCi/ml1	Column II Liquid & Solid Concentration µCi/ml2
Silver (47)	Ag-105 Ag-110m Ag-111		1x10-3 3x10-4 4x10-4
Sodium (11)	Na-24		2x10-3
Strontium (38)	Sr-85 Sr-89 Sr-91 Sr-92		1x10-3 1x10-4 7x10-4 7x10-4
Sulfur (16)	S-35	9x10-8	6x10-4
Tantalum (73)	Ta-182		4x10-4
Technetium (43)	Tc-96m Tc-96		1x10-1 1x10-3
Tellurium (52)	Te-125m Te-127m Te-127 Te-129m Te-131m Te-132		2x10-3 6x10-4 3x10-3 3x10-4 6x10-4 3x10-4
Terbium (65)	Tb-160		4x10-4
Thallium (81)	Tl-200 Tl-201 Tl-202 Tl-204		4x10-3 3x10-3 1x10-3 1x10-3
Thulium (69)	Tm-170 Tm-171		5x10-4 5x10-3
Tin (50)	Sn-113 Sn-125		9x10-4 2x10-4
Tungsten (Wolfram) (74)	W-181 W-187		4x10-3 7x10-4
Vanadium (23)	V-48		3x10-4
Xenon (54)	Xe-131m Xe-133 Xe-135	4x10-6 3x10-6 1x10-6
Ytterbium (70)	Yb-175		1x10-3

 

__________

 

¹ Values are given in Column I only for those materials normally used as gases.

² µ C1/gm for solids.  

 

 

Element  (atomic number)	Isotope	Column I Gas Concentration ì Ci/ml1	Column II Liquid & Solid Concentration ì Ci/ml2
Yttrium (39)	Y-90 Y-91m Y-91 Y-92 Y-93		2x10-4 3x10-2 3x10-4 6x10-4 3x10-4
Zinc (30)	Zn-65 Zn-69m Zn-69		1x10-3 7x10-4 2x102
Zirconium (40)	Zr-95 Zr-97		6x10-4 2x10-4
Beta and/or gamma emitting radioactive material not listed above with half-life less than 3 years		1x10-10	1x10-6

   

NOTE 1: Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing the concentrations in Schedule A the activity stated is that of the parent isotope and takes into account the daughters.

 

NOTE 2: For purposes of ARM 37.14.506 where there is involved a combination of isotopes, the limit for the combination should be derived as follows: determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration established in Schedule A for the specific isotope when not in combination. The sum of such ratios may not exceed "1" (i.e., unity) .

 

EXAMPLE:          Concentration of Isotope A in Product +

                                    Exempt concentration of Isotope A

                              Concentration of Isotope B in Product # 1

                                    Exempt concentration of Isotope B

__________

¹ Values are given in Column I only for those materials

normally used as gases.

² μC1/gm for solids.

SCHEDULE B

 

EXEMPT QUANTITIES

 

Radioactive Material                                                                                             Microcuries

 

Antimony-122 (Sb 122)                                                                                         100

Antimony-124 (Sb 124)                                                                                           10

Antimony-125 (Sb 125)                                                                                           10

Arsenic-73 (As 73)                                                                                                 100

Arsenic-74 (As 74)                                                                                                   10

Arsenic-76 (As 76)                                                                                                   10

Arsenic-77 (As 77)                                                                                                 100

Barium-131 (Ba 131)                                                                                               10

Barium-133 (Ba 133)                                                                                               10

Barium-140 (Ba 140)                                                                                               10

Bismuth-210 (Bi 210)                                                                                                 1

Bromine-82 (Br 82)                                                                                                  10

Cadmium-109 (Cd 109)                                                                                          10

Cadmium-115m (Cd 115m)                                                                                    10

Cadmium-115 (Cd 115)                                                                                        100

Calcium-45 (Ca 45)                                                                                                 10

Calcium-47 (Ca 47)                                                                                                 10

Carbon-14 (C 14)                                                                                                   100

Cerium-141 (Ce 141)                                                                                             100

Cerium-143 (Ce 143)                                                                                             100

Cerium-144 (Ce 144)                                                                                                  1

Cesium-129 (Cs 129)                                                                                             100

Cesium-131 (Cs 131)                                                                                          1,000

Cesium-134m (Cs 134m)                                                                                       100

Cesium-134 (Cs 134)                                                                                                  1

Cesium-135 (Cs 135)                                                                                                10

Cesium-136 (Cs 136)                                                                                                10

Cesium-137 (Cs 137)                                                                                                10

Chlorine-36 (Cl 36)                                                                                                     10

Chlorine-38 (Cl 38)                                                                                                     10

Chromium-51 (Cr 51)                                                                                            1,000

Cobalt-57 (Co 57)                                                                                                     100

Cobalt-58m (Co 58m)                                                                                                 10

Cobalt-58 (Co 58)                                                                                                       10

Cobalt-60 (Co 60)                                                                                                          1

Copper-64 (Cu 64)                                                                                                    100

Dysprosium-165 (Dy 165)                                                                                           10

Dysprosium-166 (Dy 166)                                                                                         100

Erbium-169 (Er 169)                                                                                                  100

Erbium-171 (Er 171)                                                                                                  100

Europium-152 (Eu 152)9.2h                                                                                      100

Europium-152 (Eu 152)13 yr                                                                                         1

Europium-154 (Eu 154)                                                                                                  1

 

Radioactive Material                                                                                                   Microcuries

 

Europium-155 (Eu 155)                                                                                               10 

Fluorine-18 (F 18)                                                                                                   1,000

Gadolinium-153 (Gd 153)                                                                                            10

Gadolinium-159 (Gd 159)                                                                                          100

Gallium-67 (Ga 67)                                                                                                     100

Gallium-72 (Ga 72)                                                                                                       10

Germanium-71 (Ge 71)                                                                                              100

Gold-198 (Au 198)                                                                                                      100

Gold-199 (Au 199)                                                                                                      100

Hafnium-181 (Hf 181)                                                                                                    10

Holmium-166 (Ho 166)                                                                                               100

Hydrogen-3 (H 3)                                                                                                      1,000

Indium-111 (In 111)                                                                                                      100

Indium-113m (In 113m)                                                                                               100

Indium-114m (In 114m)                                                                                                 10

Indium-115m (In 115m)                                                                                               100

Indium-115 (In 115)                                                                                                        10

Iodine-123 (I 123)                                                                                                         100

Iodine-125 (I 125)                                                                                                             1

Iodine-126 (I 126)                                                                                                             1

Iodine-129 (I 129)                                                                                                             0.1

Iodine-131 (I 131)                                                                                                             1

Iodine-132 (I 132)                                                                                                           10

Iodine-133 (I 133)                                                                                                             1

Iodine-134 (I 134)                                                                                                           10

Iodine-135 (I 135)                                                                                                           10

Iridium-192 (Ir 192)                                                                                                         10

Iridium-194 (Ir 194)                                                                                                       100

Iron-52 (Fe 52)                                                                                                                10

Iron-55 (Fe 55)                                                                                                              100

Iron-59 (Fe 59)                                                                                                                10

Krypton-85 (Kr 85)                                                                                                        100

Krypton-87 (Kr 87)                                                                                                          10

Lanthanum-140 (La 140)                                                                                               10

Lutetium-177 (Lu 177)                                                                                                 100

Manganese-52 (Mn 52)                                                                                                 10

Manganese-54 (Mn 54)                                                                                                 10

Manganese-56 (Mn 56)                                                                                                 10

Mercury-197m (Hg 197m)                                                                                           100

Mercury-197 (Hg 197)                                                                                                  100

Mercury-203 (Hg 203)                                                                                                    10

Molybdenum-99 (Mo 99)                                                                                              100

Neodymium-147 (Nd 147)                                                                                            100

Neodymium-149 (Nd 149)                                                                                            100

Nickel-59 (Ni 59)                                                                                                            100

Nickel-63 (Ni 63)                                                                                                              10

Nickel-65 (Ni 65)                                                                                                            100

Niobium-93m (Nb 93m)                                                                                                   10

Radioactive Material                                                                                                     Microcuries

 

Niobium-95 (Nb 95)                                                                                                         10

Niobium-97 (Nb 97)                                                                                                         10

Osmium-185 (Os 185)                                                                                                    10

Osmium-191m (Os 191m)                                                                                            100

Osmium-191 (Os 191)                                                                                                  100

Osmium-193 (Os 193)                                                                                                  100

Palladium-103 (Pd 103)                                                                                               100

Palladium-109 (Pd 109)                                                                                               100

Phosphorus-32 (P 32)                                                                                                     10

Platinum-191 (Pt 191)                                                                                                   100

Platinum-193m (Pt 193m)                                                                                            100

Platinum-193 (Pt 193)                                                                                                   100

Platinum-197m (Pt 197m)                                                                                            100

Platinum-197 (Pt 197)                                                                                                   100

Polonium-210 (Po 210)                                                                                                     0.1

Potassium-42 (K 42)                                                                                                       10

Potassium-43 (K 43)                                                                                                       10

Praseodymium-142 (Pr 142)                                                                                       100

Praseodymium-143 (Pr 143)                                                                                       100

Promethium-147 (Pm 147)                                                                                             10

Promethium-149 (Pm 149)                                                                                             10

Radium-226 (Ra 226)                                                                                                       0.1

Rhenium-186 (Re 186)                                                                                                 100

Rhenium-188 (Re 188)                                                                                                 100

Rhodium-103m (Rh 103m)                                                                                           100

Rhodium-105 (Rh 105)                                                                                                 100

Rubidium-81 (Rb 81)                                                                                                      10

Rubidium-86 (Rb 86)                                                                                                      10

Rubidium-87 (Rb 87)                                                                                                      10

Ruthenium-97 (Ru 97)                                                                                                   100

Ruthenium-103 (Ru 103)                                                                                                10

Ruthenium-105 (Ru 105)                                                                                                10

Ruthenium-106 (Ru 106)                                                                                                  1

Samarium-151 (Sm 151)                                                                                               10

Samarium-153 (Sm 153)                                                                                             100

Scandium-46 (Sc 46)                                                                                                     10

Scandium-47 (Sc 47)                                                                                                   100

Scandium-48 (Sc 48)                                                                                                     10

Selenium-75 (Se 75)                                                                                                      10

Silicon-31 (Si 31)                                                                                                          100

Silver-105 (Ag 105)                                                                                                        10

Silver-110m (Ag 110m)                                                                                                    1

Silver-111 (Ag 111)                                                                                                      100

Sodium-22 (Na 22)                                                                                                         10

Sodium-24 (Na 24)                                                                                                         10

Strontium-85 (Sr 85)                                                                                                       10

Strontium-89 (Sr 89)                                                                                                         1

 

Radioactive Material                                                                                                     Microcuries

 

Strontium-90 (Sr 90)                                                                                                         0.1

Strontium-91 (Sr 91)                                                                                                       10

Strontium-92 (Sr 92)                                                                                                       10

Sulphur-35 (S 35)                                                                                                          100

Tantalum-182 (Ta 182)                                                                                                    10

Technetium-96 (Tc 96)                                                                                                    10

Technetium-97m (Tc 97m)                                                                                           100

Technetium-97 (Tc 97)                                                                                                  100

Technetium-99m (Tc 99m)                                                                                           100

Technetium-99 (Tc 99)                                                                                                    10

Tellurium-125m (Te 125m)                                                                                             10

Tellurium-127m (Te 127m)                                                                                             10

Tellurium-127 (Te 127)                                                                                                 100

Tellurium-129m (Te 129m)                                                                                             10

Tellurium-129 (Te 129)                                                                                                 100

Tellurium-131m (Te 131m)                                                                                             10

Tellurium-132 (Te 132)                                                                                                   10

Terbium-160 (Tb 160)                                                                                                    10

Thallium-200 (Tl 200)                                                                                                    100

Thallium-201 (Tl 201)                                                                                                    100

Thallium-202 (Tl 202)                                                                                                    100

Thallium-204 (Tl 204)                                                                                                     10

Thulium-170 (Tm 170)                                                                                                    10

Thulium-171 (Tm 171)                                                                                                    10

Tin-113 (Sn 113)                                                                                                             10

Tin-125 (Sn 125)                                                                                                             10

Tungsten-181 (W 181)                                                                                                    10

Tungsten-185 (W 185)                                                                                                    10

Tungsten-187 (W 187)                                                                                                  100

Vanadium-48 (V 48)                                                                                                        10

Xenon-131m (Xe 131m)                                                                                            1,000

Xenon-133 (Xe 133)                                                                                                     100

Xenon-135 (Xe 135)                                                                                                     100

Ytterbium-175 (Yb 175)                                                                                                 100

Yttrium-87 (Y 87)                                                                                                              10

Yttrium-90 (Y 90)                                                                                                              10

Yttrium-91 (Y 91)                                                                                                              10

Yttrium-92 (Y 92)                                                                                                           100

Yttrium-93 (Y 93)                                                                                                           100

Zinc-65 (Zn 65)                                                                                                                10

Zinc-69m (Zn 69m)                                                                                                        100

Zinc-69 (Zn 69)                                                                                                           1,000

Zirconium-93 (Zr 93)                                                                                                       10

Zirconium-95 (Zr 95)                                                                                                       10

Zirconium-97 (Zr 97)                                                                                                       10

 

Any radioactive material not listed above other than alpha emitting radioactive material 0.1

Note 1: For purposes of ARM 37.14.521 where there is involved a combination of isotopes,

the limit for the combination should be derived as follows:

 

Determine the amount of each isotope possessed and 1,000 times the amount in

Schedule B for each of those isotopes when not in combination. The sum of the ratios

of those quantities may not exceed 1 (i.e., unity) .

 

Example:

 

Amt. of Isotope A possessed + Amt. of Isotope B possessed   < 1

1000 x Schedule B quantity        1000 x Schedule B quantity

              for Isotope A                          for Isotope B

 

 

SCHEDULE C

 

GROUPS OF MEDICAL USES OF RADIOACTIVE MATERIAL

 

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) Iodine-131 as sodium iodide (Na¹³¹I) for measurement of thyroid uptake.

(2) Iodine-125 as sodium iodide (Na¹²⁵I) for measurement of thyroid uptake.

(3) Iodine-131 as iodinated human serum albumin (IHSA) for determination 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 acetrizoete, or sodium iothalamate for kidney function studies.

(10) Iodine-125 as labeled iodopyracet, sodium iodohippurate, sodium diatrizoate, distrizoate 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 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) .

(22) Iodine-123 as sodium iodide (NaI) for measurement of thyroid uptake.

 

Group II. Use of prepared radiopharmaceuticals for diagnostic studies involving imaging
      and tumor localizations

 

(1) Iodine-131 as sodium iodide for thyroid imaging.

(2) Iodine-125 as sodium iodide for thyroid imaging.

(3) Iodine-131 as iodinated human serum albumin (IHSA) for brain tumor localizations and cardiac imaging.

(4) Iodine-131 as macroaggregated iodinated human serum albumin for lung imaging.

(5) Iodine-131 as colloidal (microaggregated) iodinated human serum albumin for liver imaging.

(6) Iodine-131 as labeled rose bengal for liver imaging.

(7) Iodine-131 as iodopyracet, sodium iodohippurate, sodium diatrizoate, diatrizoate methyglucamine, sodium diprotrizoate, or sodium acetrizoate for kidney imaging.

(8) Iodine-131 as sodium iodipamide for cardiac imaging.

(9) Iodine-131 as iodinated human serum albumin (IHSA) for placenta localization.

(10) Chromium-51 as sodium chromate for spleen imaging.

(11) Chromium-51 as labeled human serum albumin for placenta localization.

(12) Gold-198 in colloidal form for liver imaging.

(13) Mercury-197 as labeled chlormerodrin for kidney and brain imaging.

(14) Mercury-203 as labeled chlormerodrin for brain imaging.

(15) Selenium-75 as labeled selenomethionine for pancreas imaging.

(16) Strontium-85 as nitrate or chloride for bone imaging in patients with suspected or diagnosed cancer.

(17) Technetium-99m as pertechnetate for brain imaging.

(18) Technetium-99m as pertechnetate for thyroid imaging.

(19) Technetium-99m as pertechnetate for salivary gland imaging.

(20) Technetium-99m as pertechnetate for blood pool imaging, including placenta localization.

(21) Technetium-99m as labeled sulfur colloid for liver, spleen, and bone marrow imaging.

(22) Technetium-99m as labeled macroaggregated human serum albumin for lung imaging.

(23) Any radioactive material in a radiopharmaceutical prepared from a reagent kit listed in (4) of Group III.

(24) 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) .

(25) Fluorine-18 in solution for bone imaging.

(26) Strontium-87m for bone imaging.

(27) Iodine-125 as fibrinogen for detection and monitoring of developing deep vein thrombosis.

(28) Ytterbium-169 as labeled diethylenetriamine-pentaacetic acid (DTPA) for cistornography.

(29) Iodine-123 as sodium iodide (NaI) for thyroid imaging.

(30) Indium-113m as chloride for blood pool imaging, including placenta localization.

 

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; and

(vi) use with reagent kits for preparation and use of radiopharmaceuticals containing technetium-99m as provided in (4) and (5) of this group.

(2) Yttrium-87/strontium-87m generators for the elution of strontium-87m for bone imaging.

(3) Technetium-99m as pertechnetate for use with reagent kits for preparation and use of radiopharmaceuticals containing technetium-99m as provided in (4) and (5) of this group.

(4) Reagent kits for preparation of technetium-99m labeled:

(i) sulfur colloid for liver, spleen, and bone marrow imaging;

(ii) iron-ascorbate-diethylenetriaminepentaacetic acid complex for kidney imaging;

(iii) diethylenetriaminepentaacetic acid (Sn) for kidney imaging and kidney function studies;

(iv) diethylenetriaminepentaacetic acid (Sn) for brain imaging;

(v) human serum albumin microspheres for lung imaging;

(vi) polyphosphates for bone imaging;

(vii) macroaggregated human serum albumin for lung imaging;

(viii) distannous etidronate complex for bone imaging;

(ix) stannous pyrophosphate for bone and cardiac imaging;

(x) human serum albumin for heart blood pool imaging; and

(xi) medronate sodium for bone imaging.

(5) 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) .

(6) Tin-113/indium-113m generators for the elution of indium-113m as chloride for:

(i) blood pool imaging including placenta localization.

 

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) 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) 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) 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) 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) Iodine-125 as seeds for interstitial treatment of cancer.

SCHEDULE D

 

LIMITS FOR BROAD LICENCES

 

Radioactive Material	Col. I curies	Col. II curies
Antimony-122	1	0.01
Antimony-124	1	0.01
Antimony-125	1	0.01
Arsenic-73	10	0.1
Arsenic-74	1	0.01
Arsenic-76	1	0.01
Arsenic-77	10	0.1
Barium-131	10	0.1
Barium-140	1	0.01
Beryllium-7	10	0.1
Bismuth-210	0.1	0.001
Bromine-82	10	0.1
Cadmium-109	1	0.01
Cadmium-115m	1	0.01
Cadmium-115	10	0.1
Calcium-45	1	0.01
Calcium-47	10	0.1
Carbon-14	100	1.
Cerium-141	10	0.1
Cerium-143	10	0.1
Cerium-144	0.1	0.001
Cesium-131	100	1.
Cesium-134m	100	1.
Cesium-134	0.1	0.001
Cesium-135	1	0.01
Cesium-136	10	0.1
Cesium-137	0.1	0.001
Chlorine-36	1	0.01
Chlorine-38	100	1.
Chromium-51	100	1.
Cobalt-57	10	0.1
Cobalt-58m	100	1.
Cobalt-58	1	0.01
Cobalt-60	0.1	0.001
Copper-64	10	0.1
Dysprosium-165	100	1.
Dysprosium-166	10	0.1
Erbium-169	10	0.1
Erbium-171	10	0.1
Europium-152 (9.2h)	10	0.1
Europium-152 (13 y)	0.1	0.001
Europium-154	0.1	0.001
Europium-155	1	0.01
Fluorine-18	100	1.

   

  

  

Radioactive Material	Col. I curies	Col. II curies
Gadolinium-153	1	0.01
Gadolinium-159	10	0.1
Gallium-72	10	0.1
Germanium-71	100	1.
Gold-198	10	0.1
Gold-199	10	0.1
Hafnium-181	1	0.01
Holmium-166	10	0.1
Hydrogen-3	100	1.
Indium-113m	100	1.
Indium-114m	1	0.01
Indium-115m	100	1.
Indium-115	1	0.01
Iodine-125	0.1	0.001
Iodine-126	0.1	0.001
Iodine-129	0.1	0.001
Iodine-131	0.1	0.001
Iodine-132	10	0.1
Iodine-133	1	0.01
Iodine-134	10	0.1
Iodine-135	1	0.01
Iridium-192	1	0.01
Iridium-194	10	0.1
Iron-55	10	0.1
Iron-59	1	0.01
Krypton-85	100	1.
Krypton-87	10	0.1
Lanthanum-140	1	0.01
Lutetium-177	10	0.1
Manganese-52	1	0.01
Manganese-54	1	0.01
Manganese-56	10	0.1
Mercury-197m	10	0.1
Mercury-197	10	0.1
Mercury-203	1	0.01
Molybdenum-99	10	0.1
Neodymium-147	10	0.1
Neodymium-149	10	0.1
Nickel-59	10	0.1
Nickel-63	1	0.01
Nickel-65	10	0.1
Niobium-93m	1	0.01
Niobium-95	1	0.01
Niobium-97	100	1.
Osmium-185	1	0.01
Osmium-191m	100	1.
Osmium-191	10	0.1

      

  

Radioactive Material	Col. I  curies	Col. II curies
Osmium-193	10	0.1
Palladium-103	10	0.1
Palladium-109	10	0.1
Phosphorus-32	1	0.01
Platinum-191	10	0.1
Platinum-193m	100	1.
Platinum-193	10	0.1
Platinum-197m	100	1.
Platinum-197	10	0.1
Polonium-210	0.1	0.0001
Potassium-42	1	0.01
Praseodymium-142	10	0.1
Praseodymium-143	10	0.1
Promethium-147	1	0.01
Promethium-149	10	0.1
Radium-226	0.01	0.0001
Rhenium-186	10	0.1
Rhenium-188	10	0.1
Rhodium-103m	1,000	10.
Rhodium-105	10	0.1
Rubidium-86	1	0.01
Rubidium-87	1	0.01
Ruthenium-97	100	1.
Ruthenium-103	1	0.01
Ruthenium-105	10	0.1
Ruthenium-106	0.1	0.001
Samarium-151	1	0.01
Samarium-153	10	0.1
Scandium-46	1	0.01
Scandium-47	10	0.1
Scandium-48	1	0.01
Selenium-75	1	0.01
Silicon-31	10	0.1
Silver-105	1	0.01
Silver-110m	0.1	0.001
Silver-111	10	0.1
Sodium-22	0.1	0.001
Sodium-24	1	0.01
Strontium-85m	1,000	10.
Strontium-85	1	0.01
Strontium-89	1	0.01
Strontium-90	0.01	0.0001
Strontium-91	10	0.1
Strontium-92	10	0.1
Sulphur-35	10	0.1
Tantalum-182	1	0.01
Technetium-96	10	0.1
Technetium-97m	10	0.1

          

  

Radioactive Material	Col. I curies	Col. II curies
Technetium-97	10	0.1
Technetium-99m	100	1.
Technetium-99	1	0.01
Tellurium-125m	1	0.01
Tellurium-127m	1	0.01
Tellurium-127	10	0.1
Tellurium-129m	1	0.01
Tellurium-129	100	1.
Tellurium-131m	10	0.1
Tellurium-132	1	0.01
Terbium-160	1	0.01
Thallium-200	10	0.1
Thallium-201	10	0.1
Thallium-202	10	0.1
Thallium-204	1	0.01
Thulium-170	1	0.01
Thulium-171	1	0.01
Tin-113	1	0.01
Tin-125	1	0.01
Tungsten-181	1	0.01
Tungsten-185	1	0.01
Tungsten-187	10	0.1
Vanadium-48	1	0.01
Xenon-131m	1,000	10.
Xenon-133	100	1.
Xenon-135	100	1.
Ytterbium-175	10	0.1
Yttrium-90	1	0.01
Yttrium-91	1	0.01
Yttrium-92	10	0.1
Yttrium-93	1	0.01
Zinc-65	1	0.01
Zinc-69m	10	0.1
Zinc-69	100	1.
Zirconium-93	1	0.01
Zirconium-95	1	0.01
Zirconium-97	1	0.01

              

Any radioactive material other than source material, special nuclear material, or alpha emitting radioactive material not listed above. 0.1 0.001

History: Sec. 75-3-202, MCA; IMP, Sec. 75-3-201 and 75-3-202, MCA; NEW, 1980 MAR p. 1069, Eff. 3/28/80; TRANS, from DHES, 1996 MAR p. 433; TRANS, from DEQ, 2000 MAR p. 189.