ML18205A208

Pharmalogic Wv, Ltd., License Amendment No. 30, Control No. 609018

ML18205A208
Person / Time
Site:	03034289
Issue date:	06/28/2018
From:	Janice Nguyen Division of Nuclear Materials Safety I
To:	PharmaLogic WV, Ltd
References
609018
Download: ML18205A208 (9)

Text

NRC FORM 374 U.S. NUCLEAR REGULATORY COMMISSION MATERIALS LICENSE PAGE 1 OF 9 PAGES Amendment No. 30 Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30, 31, 32, 33, 34, 35, 36, 37, 39, 40, 70 and 71, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose(s) and at the place(s) designated below; to deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. Licensee 1. Pharmalogic WV, Ltd. 2. 9 W. Benedum Industrial Park Drive Bridgeport, WV 26330 In accordance with letters dated June 04, 2018, and June 08, 2018. 4. Expiration Date: October 31, 2022 +-----------------4

5. Docket No.: 030-34289

3. License number: 47-25375-01MD is amended in its entirety to read as follows: Reference No.: 6. Byproduct, source, and/or special nuclear material 7. Chemical and/or physical form 8. Maximum amount that licensee

9. Authorized use may possess at any one time under this license A. Any byproduct material A. Any A. 200 millicuries per A. For preparation and distribution of with Atomic Numbers 1 radionuclide and 2 curies radioactive drugs and radiochemicals through 83 with half-life total for medical use in accordance with 10 less than or equal to 120 CFR 32.72 and for non-medical use to days authorized recipients.

B. Fluorine-18

8. Any B. 1 curie total B. For preparation and distribution of radioactive drugs and radiochemicals for medical use in accordance with 10 CFR 32.72 and for non-medical use to authorized recipients.

C. Gallium-67 C. Any C. 500 millicuries total C. For preparation and distribution of radioactive drugs and radiochemicals for medical use in accordance with 10 CFR 32.72 and for non-medical use to authorized recipients.

NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET U.S. NUCLEAR REGULATORY COMMISSION License Number 47-25375-01MD Amendment No. 30 Docket or Reference Number 030-34289 PAGE 2 OF 9 PAGES 6. Byproduct, source, 7. Chemical and/or physical form 8. Maximum amount that licensee 9. Authorized use and/or special nuclear material D. Strontium-89 D. Any E. Yttrium-90 E. Any F. Molybdenum-99 F. Any G. Technetium-99m G. Any may possess at any one time under this license D. 80 millicuries total E. 1 curie total F. 200 curies total G. 200 curies total D. For preparation and distribution of radioactive drugs and radiochemicals for medical use in accordance with 1 O CFR 32.72 and for non-medical use to authorized recipients.

E. For preparation and distribution of radioactive drugs and radiochemicals for medical use in accordance with 10 CFR 32.72 and for non-medical use to authorized recipients.

F. For preparation and distribution of radioactive drugs and radiochemicals, and redistribution of used and unused Molybdenum-99/Technetium-99m generators for medical use in accordance with 10 CFR 32.72 and for non-medical use to authorized recipients.

G. For preparation and distribution of radioactive drugs and radiochemicals, and redistribution of used and unused Molybdenum-99/Technetium-99m generators for medical use in accordance with 10 CFR 32.72 and for non-medical use to authorized recipients.

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 3 OF 9 PAGES License Number Docket or Reference Number MATERIALS LICENSE 47-25375-01 MD 030-34289 SUPPLEMENTARY SHEET Amendment No. 30 6. Byproduct, source, 7. Chemical and/or physical form 8. Maximum amount that licensee 9. Authorized use and/or special nuclear may possess at any one time material under this license H. lndium-111 H. Any H. 300 millicuries total H. For preparation and distribution of radioactive drugs and radiochemicals for medical use in accordance with 10 CFR 32.72 and for non-medical use to authorized recipients.

I. lodine-123 I. Any I. 50 millicuries total I. For preparation and distribution of radioactive drugs and radiochemicals for medical use in accordance with 10 CFR 32.72 and for non-medical use to authorized recipients.

J. lodine-131 J. Any J. 5 curies total J. For preparation, including compounding of iodine-131, and distribution of radioactive drugs, and radiochemicals for medical use in accordance with 10 CFR 32.72 and for non-medical use to authorized recipients.

K. Xenon-133 K. Any K. 3 curies total K. For preparation and distribution of radioactive drugs and radiochemicals for medical use in accordance with 10 CFR 32.72 and for non-medical use to authorized recipients.

L. Samarium-153 L. Any L. 1.5 curies total L. For preparation and distribution of radioactive drugs and radiochemicals for medical use in accordance with 10 CFR 32.72 and for non-medical use to authorized recipients.

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 4 OF 9 PAGES 6. MATERIALS LICENSE SUPPLEMENTARY SHEET License Number 47-25375-01MD Amendment No. 30 Byproduct, source, 7. Chemical and/or physical form and/or special nuclear material M. Thallium-201 M. Any N. lodine-125 permitted by N. Sealed Sources (Bard 10 CFR 35.400 Brachytherapy Inc., Model STM 1251; Best Medical, Model 2301-2308 or 2309-2316; lsoAid L.L.C., Model IAl-125; North American Scientific, Model MED 3631) 0. Palladium-103 permitted

0. Sealed Sources (Best Medical, by 10 CFR 35.400 Model 2331-2335; North American Scientific, Model MED 3633; Theragenics Coporation, Model Theraseed Model 200) P. Any byproduct material P. Prepackaged Kits permitted by 10 CFR 31.11 8. M. N. 0. P. Docket or Reference Number 030-34289 Maximum amount that licensee 9. Authorized use may possess at any one time under this license 1 curie total M. For preparation and distribution of radioactive drugs and radiochemicals for medical use in accordance with 1 O CFR 32.72 and for non-medical use to authorized recipients.

0.5 curies total N. For redistribution of sealed sources initially distributed by a manufacturer licensed in accordance with 10 CFR 32.74 to authorized recipients for medical use and to authorized recipients for non-medical use. 250 millicuries total 0. For redistribution of sealed sources initially distributed by a manufacturer licensed in accordance with 10 CFR 32.74 to authorized recipients for medical use and to authorized recipients for non-medical use. 100 millicuries total P. For redistribution to specific licensees or to general licensees in accordance with 10 CFR 31.11, provided the packaging and labeling remain unchanged.

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 5 OF 9 PAGES 6. MATERIALS LICENSE SUPPLEMENTARY SHEET License Number 47-25375-01 MD Amendment No. 30 Byproduct, source, 7. Chemical and/or physical form and/or special nuclear material 0. Any byproduct material Q. Sealed Sources (International authorized under 10 CFR Isotopes Idaho Inc., Model 35.65 BM06E, BM06S, BM03-XXA, or BM03-XXL Series; Isotopes Product Laboratories, Model RV-XXX, EG-XXX, or GF Type R Series; North American Scientific Inc., Model MED 3503, MED 3550, MED 3400 or MED 3402) R. Uranium-depleted in R. Metal Uranium-235 S. Germanium-68 S. Any T. Gallium-68 T. Any 8. Q. R. S. T. Docket or Reference Number 030-34289 Maximum amount that licensee 9. Authorized use may possess at any one time under this license 100 millicuries total Q. For use in calibration and checking of the licensee's instruments and for redistribution of sealed sources initially distributed by a manufacturer licensed in accordance to 10 CFR 32. 7 4 to authorized recipients for medical use and to authorized recipients for non-medical use. 400 kilograms total R. For shielding for generators.

100 millicuries total S. For use of the Eckert and Ziegler GalliaPharm generator for preparation and distribution of radioactive drugs and radiochemicals for medical use in accordance with 10 CFR 32. 72 and for non-medical use to authorized recipients.

100 millicuries total T. For use of the Eckert and Ziegler GalliaPharm generator for preparation and distribution of radioactive drugs and radiochemicals for medical use in accordance with 10 CFR 32.72 and for non-medical use to authorized recipients.

CONDITIONS NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET U.S. NUCLEAR REGULATORY COMMISSION License Number 47-25375-01 MD Amendment No. 30 Docket or Reference Number 030-34289 PAGE 6 OF 9 PAGES 10. Licensed material may be used or stored at the licensee's facilities located at 5842B Davis Creek Road, Barboursville, West Virginia and 9 W. Benedum Industrial Park Drive, Bridgeport, West Virginia.

11. Licensed material shall only be used by, or under the supervision of: A. A pharmacist working or designated as an authorized nuclear pharmacist in accordance with 10 CFR 32.72(b)(2)(i) or (4). B. Authorized Nuclear Pharmacists:

James Cordonier II, R.Ph., Steven C. Green, R.Ph., Shelby Griffith, R.Ph., Kevin Hart, R.Ph., Garth Kistner, R.Ph., Glen Palmer, R.Ph., Laurie Stallings, R.Ph., BCNP, Richard Sucese, R.Ph., Timothy Summers, R.Ph., Dana Suttle, R.Ph., Dustin Van Dyke, Pharm.D., Zonker White, R.Ph., Anna K. Wierzbicki, R.Ph., Benjamin G. Fredrick, Pharm.D., and Amanda Wilfong, Pharm.D. 12. The Radiation Safety Officer (RSO) for this license is Steven C. Green, R.Ph. 13. Notwithstanding the requirements of 10 CFR 30.35(a)(1

), the licensee is exempt from the requirement to have a decommissioning funding plan needed for the possession and use of Ge-68/Ga-68 medical use generators (Eckert and Ziegler GalliaPharm generators), based on the commitments between the licensee and manufacturer (Eckert and Ziegler), described in the letter dated February 23 and 27, 2017. 14. This license does not authorize distribution to persons exempt from licensing.

15. A. Sealed sources shall be tested for leakage and/or contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the U.S. Nuclear Regulatory Commission under 10 CFR 32.210 or by an Agreement State. In the absence of a registration certificate, sealed sources shall be tested for leakage and/or contamination at intervals not to exceed 6 months, or at such other intervals as specified.

B. Not withstanding Paragraph A of this Condition, sealed sources designed to primarily emit alpha particles shall be tested for leakage and/or contamination at intervals not to exceed 3 months.

NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET U.S. NUCLEAR REGULATORY COMMISSION License Number 47-25375-01 MD Amendment No. 30 Docket or Reference Number 030-34289 PAGE 7 OF 9 PAGES C. In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the U.S. Nuclear Regulatory Commission under 1 O CFR 32.210 or by an Agreement State, prior to the transfer, a sealed source received from another person shall not be put into use until tested and the test results received.

D. Sealed sources need not be tested if they contain only hydrogen 3; or they contain only a radioactive gas; or the half-life of the isotope is 30 days or less; or they contain not more than 100 microcuries of beta-and/or gamma-emitting material or not more than 10 microcuries of alpha-emitting material.

E. Sealed sources need not be tested if they are in storage and are not being used. However, when they are removed from storage for use or transferred to another person, and have not been tested within the required leak test interval, they shall be tested before use or transfer.

No sealed source shall be stored for a period of more than 1 O years without being tested for leakage and/or contamination.

F. The leak test shall be capable of detecting the presence of 185 becquerels (0.005 microcuries) of radioactive material on the test sample. If the test reveals the presence of 185 becquerels (0.005 microcuries) or more of removable contamination, a report shall be filed with the U.S. Nuclear Regulatory Commission in accordance with 10 CFR 30.50(c)(2), and the source shall be removed immediately from service and decontaminated, repaired, or disposed of in accordance with Commission regulations.

G. Tests for leakage and/or contamination, including leak test sample collection and analysis, shall be performed by the licensee or other persons specifically licensed by the U.S. Nuclear Regulatory Commission or an Agreement State to perform such services.

H. Records of leak test results shall be kept in units of becquerels (microcuries) and shall be maintained for 3 years. 16. Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee, except as specifically authorized.

NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET U.S. NUCLEAR REGULATORY COMMISSION License Number 47-25375-01 MD Amendment No. 30 Docket or Reference Number 030-34289 PAGE 8 OF 9 PAGES 17. The licensee shall conduct a physical inventory every 6 months, or at other intervals approved by the U.S. Nuclear Regulatory Commission, to account for all sealed sources and/or devices received and possessed under the license. Records of inventories shall be maintained for 3 years from the date of each inventory, and shall include the radionuclides, quantities, manufacturer's name and model numbers, and the date of the inventory.

18. The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal in ordinary trash provided:

A. Before disposal as ordinary trash, the waste shall be surveyed at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to determine that its radioactivity cannot be distinguished from background.

All radiation labels shall be removed or obliterated, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee.

B. A record of each such disposal permitted under this license condition shall be retained for 3 years. The record must include the date of disposal, the date on which the byproduct material was placed in storage, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.

19. The licensee is authorized to retrieve, receive and dispose of radioactive waste from its customers, limited to radiopharmacy-supplied syringes and vials and their contents.

20. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. This license condition applies only to those procedures that are required to be submitted in accordance with the regulations.

The U.S. Nuclear Regulatory Commission's regulations shall govern unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations.

A. Application dated April 26, 2012 [ML 12122A214]

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 9 OF 9 PAGES MATERIALS LICENSE SUPPLEMENTARY SHEET Continued License Number 47-25375-01 MD Amendment No. 30 B. Letter dated June 19, 2012 [ML 12178A539]

C. Letter dated September 6, 2012 [ML 12263A215]

D. Application dated November 16, 2012 [ML 12342A305]

E. Letter dated January 10, 2013 [ML 13029A564]

F. Letter dated January 23, 2013 [ML 13024A257]

G. Letter dated January 20, 2016 [ML 15048A 157] H. Letter received March 20, 2015 [ML 15090A750]

I. Letter dated November 11, 2016 [ML 16341C333]

J. Letter dated February 7, 2017 [ML 17052A016]

K. Facility diagram received February 7, 2017 [ML 17052A072]

L. Letter dated February 8, 2017 [ML 17055B624]

M. Letter dated March 6, 2017 [ML 17072A106]

N. Letters dated March 10 and 13, 2017 [ML 17086A144]

0. Letter dated March 31, 2017 [ML 17093A698]

Date: June 28, 2018 Docket or Reference Number 030-34289 FOR THE U.S. NUCLEAR REGULATORY COMMISSION By: ~/) Ja~ Region 1