ML20133M027
| ML20133M027 | |
| Person / Time | |
|---|---|
| Site: | 07000299 |
| Issue date: | 01/31/1978 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20133G976 | List:
|
| References | |
| FOIA-96-343 NUDOCS 9701220223 | |
| Download: ML20133M027 (1) | |
Text
._
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hg 1 of__Jages U. S. NUCLEAR REZULATCRY CCMMISSION MATER!ALS LICENSE Pursuant to the Atomic Energy Act of 1954. as amended, the Energy Reorganization Art of 1974 IPublic 1.a 1
4383, and Title 10. Code of Federal Regulations. Chapter 1. l' arts 30. 31, 32. 33. 34, 35, 36, 40 and 70, a d authorizing the licensee in statements and representations heretofore made by the licensee, a license is hereby issuedesignated below; to une such receive. acquire, possess, and transfer byproduct, source, and special nucle d
to receive it in accordance with the regulations of the applicable Partis);
material. This license shall be deemed to contain the conditions specified in Section 183 of the Atomic En as amended, and is subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commiss hereafter in effect and to any conditions specified below.
Licensee f
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- 4. Expiration date aM
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Docket or I ff
- 5. Reference No.
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- 7. Chemical and/or physical
- 8. Maximum amount that licensee
- 6. Byproduct, source, and/or may possess at any one time form special nuclear material under this license
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For the U. S. Nuclear Regulatory Commission
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..o o r e.o s e :. o s o <, t o n e r.
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".< o u m & c o October 8, 1974 Ref.:
License No. 24-04206-01 Maryland Heights, Mo.
License No. 29-13564-01 Carlstadt, N. J.
Mr. Bernard Singer Chief, Materials Branch Directorate of Licensing Office of Regulation
,/
U.S. Atomic Energy Commission Washington, D.C.
20545
Dear Mr. Singer:
, The following informational data are submitted by Mallinckrodt,
[
Inc. in application for a specific license to:
(1)
Manufacture and distribute radiopharmaceuticals cen-taining by-product material for use by persons licensed pursuant to Section 35.14 of this chapter for the uses listed in Group I, Group II, Group IV, and Group V of Schedule A, Section 35.100 of this chapter - per Section 32.72 of 10 CFR Part 32;
[
(2)
Manufacture and distribute generators or reagent kits containing by-product material for preparation of radio-pharmaceuticals by persons licensed pursuant to Section 35.14 of this chapter for the uses listed in Group III of Schedule A, Section 35.100 of this chapter per Section 32.73 of 10 CFR Part 32; (3)
Manufacture and distribute sources containing by-product material to persons licensed pursuant to Section 35.14 of this chapter for use as a calibration or reference source -
per Section 32.74 of 10 CFR Part 32.
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h t & 8 t t,* A C F U T lC A Hf $[ ARCH AND Of vlL ONI N' Division 6
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Ii Mr. Bernard Singer Page 2 October 8, 1974 6
The Mallinckrodt, Inc. manufacturing and distribution locations are:
Mallinckrodt/ Nuclear j
2703 Wagner Place Maryland Heights, Missouri 63042 Mallinckrodt/ Nuclear 463 Barell Avenue Carlstadt, New Jersey 07072 j
should you have any questions or desire further information, please do not hesitate to contact us.
Sincerely,
~
[
Lloyd G.
Struttman Project Manager, Radiopharmaceuticals Medical Department LGS /sm Enclosures i
1 52440
1 MALLINCKRODT, It'O.
l St. Louis, Mio:
.r i p
TABLE OF CONTENTS Page i
1
/
GROUPS I, II, IV and V Packaging data and reference keys.
2 Group labe1~ types...
9 New Drug Applications.
11 i
DHEW/PHS/FDA Establishment License No. 77.
31 GROUP III (Generators)
Packaging data and reference keys.
35 Radiation exposure data.
36
{
Radiation safety procedures.
37 Group labeling.
46 New Drug Application.
47 GROUP III (Reagent Kits)
TechneColl Kit 48 TechneScan PYP Kit 55 TechneScan MAA Kit 61 Group labeling.
67 New Drug Applications.
68 DHEW/PHS/FDA Establishment License No. 77.
70 t
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e ti s
1 l
MALLINCKRODT, INC.
St. Louis, Mis uri TABLE OF CONTENTS (cont'd)
Page CALIBRATION AND REFERENCE SOURCES Technetium-99m Calibration Source.
. 73 Molybdenum-99 Calibration Source
. 73 Europium 152-154 Reference Source.
. 73 Cesium-137 Reference Source.
. 75
[
SHIPPING PACKAGE AND IMMEDIATE CONTAINER TYPES Type A - 110 series safes.
78 79 Type A - 302 safe.
. 80 6
Type B Type C - 300 series safes.
. 81 Type C - S series safes.
. 82 Type D - K series safes.
. 83
. 84 Type E i
. 85 Type F
. 86 Type G..
. 87
)
Type O i
i a
+
1 4
.._ ~ _
MALLINCKRODT,~INC.
j St. Louis, Mis:
.r i INTRODUCTION 1
The Immediate Shipping Container / Safe and Shipping Package types referred to throughout the tables and text of this application are described by annotated drawings on pages 78 j
to 87 The lead shields (safes) that are part of the immediate containers are denoted by cross-hatching.
In the tables, under Groups I, II, IV and V, the Product Column captioned "No. X Size (mci) Cal. Date", the No. refers to the number of discrete sources of the size indicated that are shipped in a single shipping package of the type listed in the table.
Each such source is contained in the type of immediate shipping container / safe assembly listed.
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MALLINCKRODT, INC.
St. Louis, Missouri Oroups I, II, IV and V Section ?2.72 of to CFR Part 9 Immedlate Max.. mr/h r Max. Days Shipping Shipping Package Shipped G roup Product Container /
Package Surface Before Label NDA No. X Size /n.Cl) Cal. Date Safe Type Type Cal. Date Cal. Date Type No.
[-
Gold Au 198 Injection (B)17-261 (Diagnostic) 114 A
19.4 7
\\, ),
1x2 3
114 8
33.6 2x2 3x2 114 B
43 8 4x2 114 B
hh.1 Sodium Chromate Cr $1 (A)16-708
[
b qd Injection 1 x 0.25 110 A
O.5 30 2 x 0.25 110 B
1.1 3 x 0.25 110 B
1.6 4 x 0.25 110 B
1.7 Ferrous Citrate Fe 59 (A)16-729 Injec tion g,.(\\
1 x 0.125 110 A
13 3 30 1
1 x 0.25 110 A
26.6 2 x 0.25 110-B 48.9 3 x 0.25 110 B
90 3 4 x 0.25 110 a
108 Chlormerodrin lig 197 (B) 16 642 Injection h
- y 110 A
6.6 6'
1x05 k'
1 x 1.0 112 A
O.0 1x50 112 A
O.1 2 x 5.0 112 B
0.1 3x50 112 B
0.1 4x50 112 B
0.1 Chlormerodrin Hg 203 (B)16-646 Injection M
1 x 1.0
\\U' 112 A
33 8
1 x 2.0 112 A
6.5 1x50 112 A
16.3 2x50 112 B
37.0 3x50 112 B
63 0 4x50 112 B
69 5 Sodium Iodide 1125 4 (5)17-278 Oral Solution 9
1 x 0.25 110 A
1.4 1
1 x 2.0 112 A
0.0 6
1n30 112 A
0.0 1 x 4.0 112 A
0.0 1 x
'.0 112 A
0.0 2 x P.0 112 B
0.0
, d-3-x 8.0 112 B
0.0 0 C 't 4 4 x 8.0 112 B
0.0 C
b 2
MALLItiCKRODT. LNC.
St. Louis, Missouri Groups I, II, -IV and V (con.'d)
Immed iate Max. mr/hr Max. Days Shipping Shipping Package Shipped Group Product Containe r/
Package Surface Be fore Label NDA No. X Size (mC1) Cal. Date Safe Type Type Cal. Date Cal. Date Type No.
Sodium Iodide I125 [
(D)17-222
[
Capsules ge 1 x 0.1 110 A
0.6 30 20 x 0.1 110 A
10 9 2 x 20 x 0.1 110 B
28.4 3 x 20 x 0.1 110 B
44.0 4 x 20 x 0.1 110 B
45 2 i
Radiciodinated I124 (A)
License Serum Albumin (Hucan)
No. 77 i
IHSA Injection 1 x 0.1 110 A
0.6 30 2 x 0.1 110 B
1.k 3 x 0.1 110 B
2.2 5
4 x 0.1 110 B
2.5 1 x 0.5 110 A
2.7 2x05 110 B
7.1 3x05 110 B
11.0
[
4x05 110 B
11.3 Isojex Syringes IHSA (A)
License l
1125 Injection No. 77
)
3 x 0.01
- 3 can C
05 30 5 x 0.01
- 3 can C
0.6 8 x 0.01
- 3 can C
09 10 x 0.01
- 3 can
'C 1.3 s
i Plasma Volume Kit (A)
License Radiolodinated (I125)
No. 77 i
Serum Albumin 3 x 0.01 F
1.8 30 5 x 0.01 F
2.8 Oleic Acid I125 (A)17-231 Capsules
\\
1 x 0.05 110 A
0.3 30 2' x 0.05 110 A
05 3 x 0.05 110 A
0.8 4 x 0.05 110 A
1.1 5 x 0.05 110 A
1.4 10 x 0.05 110 A
27 Fatty Acid Absorption (A)17-251 Test Kit (Oleic Acid 1125) 1 x 0.05 E
7.6 30 2 x 0.05 E
14.2
MALLINCKRODT, INC.
i St. Louis, Missouri l l Groups I, II, IV and V (cont'a, Icune d iat e Max, mr/hr Max. Days Shipping Shipping Package Shipped Group Product Container /
Package Surface Be fo re Label NDA No. X Size (mC1) Cal. Date Safe Type Type Cal. Date Cal. Date Type No.
Sodium Iodide I131 (D) 16 517 Capsules (Diagnostic) 14,5()
302 A
0.6 8
5 x 0.015 302 A
13 10 x 0.015 15 x 0.015 302 A
19 20 x 0.015 302 A
2.5 5 x 0.025 302 A
1.1 10 x 0.025 302 A
2.1 15 x 0.025 302 A
32 20 x 0.025 302 A
4.2 5 x 0.05 302 A
2.1 10 x 0.05 302 A
4.2 15 x 0.05 302 A
6.3 20 x 0.05 302 A
8.4 5 x 0.1 302 A
4.2 10 x 0.1 302 A
8.4 15 x 0.1 302 A
12.6 20 x 0.1 302 A
16.8 jj',
2 x 20 x 0.1 302 B
20 9 3 x 20 x 0.1 302 B
35 2 4 x 20 x 0.1 302' B
36.2 Sodium Iodide 1131 Oral (F)16-515 Solution (Therapeutic)5 1 x 1.0 g
112 A
16,8 1
1x50
\\V 114 A
42.0 1 x 10.0 114 A
84.0 1 x 20.0 114 A
168 1 x 50.0 S4 C
33 9 1 x 100.0 S6 C
16.9 1 x 200.0 S7 C
16.9 Sodium Iodide I131 (F) 16 517 Capsules (Therapeutic) 1 x 1.0 302 A
2.7 1
1x50 302 A
13.6 1 x 10.0 302 A
27.1 1 x 20.0 302 A
54.2 1 x 50 0 304 C
33 9 1 x 10 308 C
4.2 1 x 200.0 308 C
85 Radiciodinated (I131)
(D)
License Serum Albumin (Human) IHSA No. 77 1131 Injection d]
110 A
10.2 8
1 x 0.25 1 x 0 50 110 A
20.4 1 x 1.0 112 A
16.8 2 x 1.0 112 B
21.3 4
MALLlhCKKUU1, AW.
l St. Louis, Missouri I
Groups I, II, IV cnd V (cot. d)
Immediate Max. mr/hr Max. Days Shipping Shipping Package Shipped Group Product Container /
Package Surface-Be fore Label NDA No. X Size (mci) Cal. Date Safe Type Type Cal. Date Cal. Date Type No.
Radioiodinated (I131)
(cont'd) 112 B
26.3 l]
3 x 1.0 112 B
38.6 4 x 1.0 '
1 x 2.0 11h A
16.8 2 x 2.0 114 B
20 9 3 x 2.0 114 B
35.2 4 x 2.0 114 B
36.2 Isojex Syringes IHSA (D)
License
[
I131 Injection No. 77
^
3 x 0.01 g
- 3 can C
0.6 10 5 x 0.01 6
- 3 can C
09 8 x 0.01 f3 can C
15 10 x 0.01 f3 can C
1.6 Plasma Volume Kit (A)
License Radioiodinated (I131)
No. 77
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Serum Albumin (Human)%
3 x 0.01 F
23 11 5 x 0.01 F
4.3 Aggregated Radioiodinated (B)
License (1131) Albumin (Human)
No. 77 Injection q
1 x 1.0 iI 112 A
16.8 9
2 x 1.0 112 B
21.3 i
3 x 1.0 112 B
26.3 4 x 1.0 112 B
38.6 1 x 2.0 114 A
16.8 2 x 2.0 114 B
20 9 3 x 2.0 114 B
35.2 4 x 2.0 114 B
36.2 i
1x30 114 A
25.2 2x30 11h B
31.3 3x30 114 3
52.7 4x30 114 B
54.4
~
Sodium Iodohippurate 1131 (D)16-666 Rippuran I131 Injection D
110 A
20.4 8
1x05 N,(A 110 B
31 9 2x05 3x05 110 B
39.9 4x05 110 B
52.5 1 x 1.0 112 A
16.8 2 x 1.0 112 B
21 3 3 x 1.0 112 B
26.3 4 x-1.0 112 B
38.6 5
MALLINCKRODT, INC.
l St. Louic, Missouri i
Croups I, II, IV and V (cont'd; Immediate Max mr/hr Max. Days Shipping Shipping Package Shipped Group l
Product Container /
Package Surface Before Label NDA No. X Size (mci) Cal. Date Safe Type Type Cal. Da te Cal Date Type No.
Sodium Rose Bengal (D) 16 665
[
1131 Injection 1 x 0.25
\\V 110 A
10.2 8
2 x 0.25 110 B
16.0 3 x 0.25 110 B
20.0 4 x 0.25 110 B
26.2 1 x 1.0 112 A
16.8 2 x 1.0 112 B
21.3 3 x 1.0 112 B
26.3 4 x 1.0 112 B
38.6 i
h,7]
(A) 17 217 Triolein I131 Oral Solution 1x05 110 A
20.4 1
1 x 1.0 112 A
16.8 l'x 2.0 114 A
16.8 1 x 3.0 114 A
25.2 1 x 4.0 114 A
33.6
['
1x50 114 A
42.0 2x50 114 B
52.2 3x50 114' B
87 9 4x50 114 B
90.6 Triolein I131 (A)17-216 Cap sule s QN 1 x 0.025 110 A
1.0 8
[,
2 x 0.025 110 A
2.0 3 x 0.025 110 A
3.1 5 x 0.025 110 A
5.1 10 x 0.025 110 A
10.2 1 x 0.05 110 A
2.0 2 x 0.05 110 A
4.1 3 x 0.05 110 A
6.1 5 x 0.05 110 A
10.2 to x 0.05 110 A
4.1 1 x 0.1 110 A
4.1 2 x 0.1 110 A
8.2 3 x 0.1 110 A
12.2 5 x 0.1 110 A
20.4 10 x 0.1 110 A
40.8 Neutral Fat Absorption (A) 17 216 Test Kit (Triolein 1131) 1 x 0.1 E
12.4 5
2 x 0,1 E
32 5 6
MALLINCKRODT. D1C.
g I
St. Louis, Missouri Groups I, II, IV and V (cont'd)
Immediate Max. mr/hr Max. Days Shipping Shipping Package Shipped Group Product Container /
Package Surface Before Label NDA No. X Size (mci) Cal. Date Safe Type Type Cal. Date Cal. Date Type No.
(C)11-777
[
Sodium Phosphate P32 f
Capsules 1 x 1.0 110 A
0.1 1
1 x 2.0 110 A
0.2 1x30 IP A
0.3 1x50 IN A
0.4 1 x 10.0 s 'I.
A 0.8 1 x 5 0+10.0 110 B
13 2 x 10.0 110 B
1.7 r
1 Sodium Phosphate P32 (C)11-777 Injection 1x50 110 A
0.4 5
2x50 110 B
0.8 3x50 110 B
1.3 4x50 110 B
1.8 Sodium Phosphate P32 (C) 11 777
[1 Serial Capsules 1 x 1.8 110 A
0.2 1
2 x 1.8 110 B
03 j
3 x 1.8 110 5
0.4 4 x 1.8 110 B
0.6 Sodium Phosphate P32 (C)11-777 Serial Injection 1x15 110 A
0.1 1
(
2 x 1.5 110 B
0.3 3 x 1.5 110 B
0.4 hx15 110 B
0.5 Chromic Phosphate P32 (G)17-084 110 A
0.4 1
1x50
[' 0 110 A
0.8 4
1 x 10.0 1 x 15 0 110 A
1.3 1 x 20.0 110 A
1.7 J
i Selenomethionine Se 75.Inj (B)
I'/-098 1 x 0.25 d
110 A
15.6 30 0
ito 3
19,3 2 x 0.25
\\y 110 B
32.3 3 x 0.25 1 x 1.0 112 A
6.4 2 x 1.0 112 B
7.8 3 x 1.0 112 B
11 7 4 x 1.0 112-B 12.7 I
s e
7
HALLINCKROD f, ING.
g St. Louis; Missouri I
Croups I, II, IV and V (cont %,
Inunediate Max. mr/hr Max. Days Shipping Shipping Package Shipped Group Product Container /
Package Surface Before Label NDA No. X Size (mci) Cal. Date Safe Type Type Cal. Date Cal. Date Type No.
Strontium Nitrate Sr 8' (B) 16 698 Injection 1 x 0.1
\\
110 A
4.5 30 1 x 0.25 110 A
11.2 1x05 110 A
24.5 2x05 110 B
46.0 3x05 110 B
75 7 4x05 110 B
63.5 Sodium Pertechnetate (E)17-121 I
7 Tc 99m injection 1
k, 113 A
0.0 1.125 1 x 5.0 (7
1 x 10.0 113 A
0.0 1 x 15 0 113 A
O.0 1 x 20.0 113 A
0.0 1 x 25 0 113 A
0.01 2 x 25 0 113 B
0.01 3 x 25 0 113 B
0.01 r
4 x 25 0 113 B
O.01 L
Sodium Pertechnetate (E)17-121 Tc 99m Injection High Concentration 1 x 50.0 113 A
0.01 i.125 1 x 75 0 113 A
0.02 1 x 100.0 114 A
0.0 1 x.150.0 114 A
0.0
[
1 x 200.0 114 A
0.0 1 x 250.0 lik A
O.0 2 x 250.0 114 B
0.0 3 x 250.0 114 8
0.0 4 x 250.0 114 B
0.0 Technetium Tc 99m (B)17-026 0,U Sulfur Colloid Inj.
q
,i 1 x 2.0 113 A
0.0 1.125 T
1x30
\\
113 A
0.0 1x50 113 A
0.0 1 x 10.0 113 A
0.0 2 x 10.0 113 B
0.0 3 x 10.0 113 B
0.0 4 x 10.0 113 B
0.0 Red Cell Tagging Kit (A)16-708 Sodium Chromate Cr 51 1 x 0.25 110 G
1.4 30 g
MALLINCKRODT, INC.
St. Louis, Mist tri Group Labelinq Type Label (A)
This radiopharmaceutical is licensed by the U.S. Atomic Energy Commission for distribution to persons licensed pursuant to Sections 35.14 and 35.100 Group I of 10 CFR
_Part 35.
(B)
This radiopharmaceutical is licensed by the U.S. Atomic Energy Commission for distribution to persons licensed pursuant to Sections 35.14 and 35.100 Group II of 10 CFR Part 35.
I (C)
This radiopharmaceutical is licensed by the U.S. Atomic Energy Commission for distribution to persons licensed pursuant to Sections 35.14 and 35.100 Group IV of 10 CFR Part 35.
j (D)
This radiopharmaceutical is licensed by the U.S. Atomic l
Energy Commission for distribution to persons licensed pursuant to Sections 35.14 and 35.100 Groups I and II of 10 CFR.Part 35.
l (E)
This radiopharmaceutical is licensed by the U.S. Atomic Energy Commission for distribution to persons licensed I
pursuant to Sections 35.14 and 35.10$* Groups II and III l
of 10 CFR Part 35.
( F)
This radiopharmaceutical is licensed by the U.S. Atomic l
Energy Commission for distribution to persons licensed pursuant to Sections 35.14 and 35.100 Groups IV and V of 10 CFR Part 35.
+
}
( G)
This radiopharmaceutical is licensed by the U.S. Atomic Energy Commission for distribution to persons licensed pursuant.to Sections 35.14 and 35.100 Group IV (Intra-cavitary Use) of 10 CFR Part 35.
3
- i
MALLINCKRODT,
NC.
St. Louis, Mi.-ouri Group Labelino (cont'd)
The appropriate Group label will be affixed to or otherwise contained in the radiopharmaceutical product package insert.
All radiopharmaceutical products of Groups I, II, IV and V
{
bear labeling which identifies the radionuclide, quantity and date of assay.
Such labeling is part of that required by the Food and Drug Administration.
4 W
^
10
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