ML18205A206
| ML18205A206 | |
| Person / Time | |
|---|---|
| Site: | 03034289 |
| Issue date: | 06/28/2018 |
| From: | Janice Nguyen Division of Nuclear Materials Safety I |
| To: | Gadziala R PharmaLogic WV, Ltd |
| References | |
| 609018 | |
| Download: ML18205A206 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION REGION I 2100 RENAISSANCE BLVD. KING OF PRUSSIA, PA 19406-2713 June 28, 2018 Reid Gadziala, Pharm.D., BCNP, MBA Director, Quality and Regulatory Affairs PharmaLogic WV, Ltd. 9 W. Benedum Industrial Park Drive Bridgeport, WV 26330
SUBJECT:
PHARMALOGIC WV, LTD., LICENSE AMENDMENT, MAIL CONTROL NO. 609018
Dear Dr. Gadziala:
This refers to your license amendment requests received June 4 and 8, 2018. Please find enclosed Amendment No. 30 authorizing Benjamin G. Fredrick, Pharm.D. and Amanda Wilfong, Pharm.D. as authorized nuclear pharmacists.
An environmental assessment for this action was not required, since this action is categorically excluded under 10 CFR 51.22(c)(14).
Please review the enclosed document carefully and be sure that you understand and fully implement all the conditions incorporated into the amended license. If there are any errors or questions, please contact me at (610) 337-5006 or via electronic mail at janice.nguyen@nrc.gov so that appropriate corrections or answers can be provided.
You will be periodically inspected by the NRC. Failure to conduct your program in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspondence with NRC will result in enforcement action(s) against you. This could include issuance of a Notice of Violation, or Imposition of a Civil Penalty, or an Order Suspending, Modifying or Revoking Your License as specified in the NRC Enforcement Policy. The NRC Enforcement Policy is available at: http://www.nrc.gov/reading-rm/doc-collections/enforcement/.
An electronic version of the NRC's regulations is available on the NRC Web Site at: www.nrc.gov.
Additional information regarding medical uses of radioactive materials may be obtained on the NRC Web Site at: http://www.nrc.gov/materials/miau/med-use-toolkit.html.
This site also provides the updated Training and Experience NRC Form 313A series of forms and guidance, as well as information on the revised regulations for naturally-occurring and accelerator-produced radioactive materials (NARM).
R. -<5adzfala 2 The NRC's Safety Culture Policy Statement became effective in June 2011. While a policy statement and not a regulation, it sets forth the agency's expectations for individuals and organizations to establish and maintain a positive safety culture. You can access the policy statement and supporting material that may benefit your organization on NRC's safety culture Web Site at: http://www.nrc.gov/about-nrc/safety-culture.html.
We strongly encourage you to review this material and adapt it to your particular needs in order to develop and maintain a positive safety culture as you engage in NRG-regulated activities.
In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter and its enclosure will be available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS). ADAMS is accessible from the NRC Web Site at: http://www.nrc.gov/reading-rm/adams.html.
Thank you for your cooperation.
License No. 47-25375-01 MD Docket No. 030-34289 Mail Control No. 609018
Enclosure:
Amendment No. 30 cc: Steven C. Green, R.Ph. Director of Operations
& RSO Sincerely, r11~ Janice Nguyen, Senior Health Physicist Medical and Licensing Assistance Branch Division of Nuclear Materials Safety Region I R. Gadiiala 2 The NRC's Safety Culture Policy Statement became effective in June 2011. While a policy statement and not a regulation, it sets forth the agency's expectations for individuals and organizations to establish and maintain a positive safety culture. You can access the policy statement and supporting material that may benefit your organization on NRC's safety culture Web Site at: http://www.nrc.gov/about-nrc/safety-culture.html.
We strongly encourage you to review this material and adapt it to your particular needs in order to develop and maintain a positive safety culture as you engage in NRG-regulated activities.
In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter and its enclosure will be available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS). ADAMS is accessible from the NRC Web Site at: http://www.nrc.gov/reading-rm/adams.html.
Thank you for your cooperation.
License No. 47-25375-01 MD Docket No. 030-34289 Mail Control No. 609018
Enclosure:
Amendment No. 30 cc: Steven C. Green, R.Ph. Director of Operations
& RSO Sincerely, Janice Nguyen, Senior Health Physicist Medical and Licensing Assistance Branch Division of Nuclear Materials Safety Region I DOCUMENT NAME: G:\WBL Documents\WBL License Cover Letter\L47-25375-01 MD.609018.docx
[LAT to enter ADAMS Accession No.] SUNSI Review Complete:
JNguyen After declaring this document "An Official Agency Record" it will be released to the Public. T o receive a copy of this document, indicate in the box: "C" = Copy w/o attach/encl "E" = Copy w/ attach/encl "N" = No copy OFFICE Rl:DNMS IN I I I NAME JNauven / ~/) y DATE '*Ji-IP' OFFICIAL RECORD COPY