Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance 

About Commercial 

Radiopharmacy Licenses

Draft Report for Comment

Office of Nuclear Material Safety and Safeguards

NUREG-1556

Volume 13, Rev. 2 
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Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance 

About Commercial 

Radiopharmacy Licenses

Draft Report for Comment

Manuscript Completed: December 2016

Date Published: December 2016

Prepared by: 

R. L. Elliott

R. G. Gattone

C. Graham

J. F. Katanic

L. Roldan-Otero

T. Thompson

Office of Nuclear Material Safety and Safeguards 

NUREG-1556

Volume 13, Rev. 2 

1 COMMENTS ON DRAFT REPORT 

2 Any interested party may submit comments on this report for consideration by the U.S. Nuclear 

3 Regulatory Commission (NRC) staff. Comments may be accompanied by additional relevant 

4 information or supporting data. Please specify the report number NUREG–1556, Volume 13, 

5 Revision 2, in your comments, and send them by the end of the comment period specified in the 

6 Federal Register notice announcing the availability of this report. 

7 Addresses: You may submit comments by any one of the following methods. Please include 

8 Docket ID NRC-2016-0190 in the subject line of your comments. Comments submitted in 

9 writing or in electronic form will be posted on the NRC Web site and on the Federal rulemaking 

10 Web site at http://www.regulations.gov. 

11 Federal Rulemaking Web site: Go to http://www.regulations.gov and search for documents 

12 filed under Docket ID NRC-2016-0190. Address questions about NRC dockets to 

13 Carol Gallagher at 301-415-3463 or by e-mail at Carol.Gallagher@nrc.gov. 

14 Mail comments to: Cindy Bladey, Chief, Rules, Announcements, and Directives Branch 

15 (RADB), Division of Administrative Services, Office of Administration, Mail Stop: 

16 OWFN-12-H8, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 

17 For any questions about the material in this report, please contact: Said Daibes, 

18 Health Physicist at 301-415-6863 or by e-mail at Said.Daibes@nrc.gov.Please be aware that 

19 any comments that you submit to the NRC will be considered a public record and entered into 

20 the Agencywide Documents Access and Management System. Do not provide information you 

21 would not want to be publicly available.

iii 

1 ABSTRACT 

2 This technical report contains information intended to provide program-specific guidance and 

3 assist applicants and licensees in preparing applications for materials licenses for commercial 

4 radiopharmacies. In particular, it describes the types of information needed to complete 

5 U.S. Nuclear Regulatory Commission (NRC) Form 313, “Application for Materials License.” 

6 This document describes both the methods acceptable to the NRC license reviewers in 

7 implementing the regulations and the techniques used by the reviewers in evaluating the 

8 application to determine if the proposed activities are acceptable for licensing purposes. 

9 Paperwork Reduction Act Statement 

10 This NUREG references information collection requirements that are subject to the Paperwork 

11 Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were approved 

12 by the Office of Management and Budget (OMB), approval numbers 3150-0044; 3150-0014; 

13 3150-0035; 3150-0017; 3150-0016; 3150-0001; 3150-0010; 3150-0214; 3150-0020; 3150-0009; 

14 3150-0008; 3150-0120; and 3150-0028. 

15 Public Protection Notification 

16 The NRC may not conduct or sponsor, and a person is not required to respond to, a request for 

17 information or an information collection requirement unless the requesting document displays a 

18 currently valid OMB control number.

v 

1 FOREWORD 

2 The U.S. Nuclear Regulatory Commission’s (NRC’s) NUREG-1556 technical report series 

3 provides a comprehensive source of reference information about various aspects of materials 

4 licensing and materials program implementation. These reports, where applicable, describe a 

5 risk-informed, performance-based approach to licensing consistent with the current regulations. 

6 The reports are intended for use by applicants, licensees, license reviewers, and other NRC 

7 personnel. The NUREG–1556 series currently includes the following volumes: 

Volume No. Volume Title 

1 Program-Specific Guidance About Portable Gauge Licenses 

2 Program-Specific Guidance About Industrial Radiography Licenses 

3 Applications for Sealed Source and Device Evaluation and Registration 

4 Program-Specific Guidance About Fixed Gauge Licenses 

5 Program-Specific Guidance About Self-Shielded Irradiator Licenses 

6 Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses 

7 Program-Specific Guidance About Academic, Research and Development, and 

Other Licenses of Limited Scope Including Electron Capture Devices and X-Ray 

Fluorescence Analyzers 

8 Program-Specific Guidance About Exempt Distribution Licenses 

9 Program-Specific Guidance About Medical Use Licenses 

10 Program-Specific Guidance About Master Materials Licenses 

11 Program-Specific Guidance About Licenses of Broad Scope 

12 Program-Specific Guidance About Possession Licenses for Manufacturing 

and Distribution 

13 Program-Specific Guidance About Commercial Radiopharmacy Licenses 

14 Program-Specific Guidance About Well Logging, Tracer, and Field Flood 

Study Licenses 

15 Guidance About Changes of Control and About Bankruptcy Involving 

Byproduct, Source, or Special Nuclear Materials Licenses 

16 Program-Specific Guidance About Licenses Authorizing Distribution to 

General Licensees 

17 Program-Specific Guidance About Special Nuclear Material of Less Than 

Critical Mass Licenses 

18 Program-Specific Guidance About Service Provider Licenses 

19 Guidance for Agreement State Licensees About NRC Form 241 “Report of 

Proposed Activities in Non-Agreement States, Areas of Exclusive Federal 

Jurisdiction, or Offshore Waters” and Guidance for NRC Licensees Proposing to 

Work in Agreement State Jurisdiction (Reciprocity) 

20 Guidance About Administrative Licensing Procedures 

21 Program-Specific Guidance About Possession Licenses for Production of 

Radioactive Material Using an Accelerator 

8 The current document, NUREG–1556, Volume 13, Revision 2, “Consolidated Guidance About 

9 Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses,” 

10 is intended for use by applicants, licensees, and NRC staff. This revision provides a general 

11 update to the previous information contained in NUREG–1556, Volume 13, issued 

12 November 2007. 
vi 

1 This report takes a risk-informed, performance-based approach to licensing the use of 

2 byproduct material in commercial radiopharmacy. A team composed of staff from NRC 

3 Headquarters, NRC regional offices, and Agreement States prepared this document, drawing on 

4 their collective experience in radiation safety in general and as specifically applied to 

5 commercial radiopharmacy. 

6 NUREG–1556, Volume 13, Revision 2, is not a substitute for NRC or Agreement State 

7 regulations. The approaches and methods described in this report are provided for information 

8 only. Methods and solutions different from those described in this report may be acceptable if 

9 they include a basis for the staff to make the determinations needed to issue or renew a license. 

10 

11 Daniel S. Collins, Director 

12 Division of Material Safety, State, Tribal, and Rulemaking Programs 

13 Office of Nuclear Material Safety and Safeguards
vii 

1 TABLE OF CONTENTS 

2 ABSTRACT ................................................................................................................................. iii 

3 FOREWORD ................................................................................................................................. v 

4 FIGURES ..................................................................................................................................... xi 

5 TABLES ....................................................................................................................................... xi 

6 ACKNOWLEDGMENTS ............................................................................................................ xiii 

7 ABBREVIATIONS ...................................................................................................................... xv

8 1 PURPOSE OF REPORT ................................................................................................ 1-1

9 2 AGREEMENT STATES ................................................................................................. 2-1

10 3 MANAGEMENT RESPONSIBILITY .............................................................................. 3-1

11 3.1 Commitments and Responsibilities .................................................................... 3-1

12 3.2 Safety Culture ..................................................................................................... 3-2

13 4 APPLICABLE REGULATIONS ..................................................................................... 4-1

14 5 HOW TO FILE ................................................................................................................ 5-1

15 5.1 Application Preparation ...................................................................................... 5-1

16 5.2 Where to File ...................................................................................................... 5-1

17 5.3 Paper Applications ............................................................................................. 5-2

18 5.4 Electronic Applications ....................................................................................... 5-2

19 6 IDENTIFYING AND PROTECTING SENSITIVE INFORMATION ................................. 6-1

20 7 APPLICATION AND LICENSE FEES ........................................................................... 7-1

21 8 CONTENTS OF AN APPLICATION .............................................................................. 8-1

22 8.1 Item 1: License Action Type .............................................................................. 8-1

23 8.2 Item 2: Name and Mailing Address of Applicant................................................ 8-2

24 8.2.1 Notification of Bankruptcy Proceedings ................................................ 8-2

25 8.3 Item 3: Address(es) Where Licensed Material Will Be Used 

26 or Possessed ........................................................................................ 8-2

27 8.4 Item 4: Person to Be Contacted About This Application .................................... 8-4

28 8.5 Item 5: Radioactive Material .............................................................................. 8-4

29 8.5.1 Sealed and/or Unsealed Byproduct Material ......................................... 8-4

30 8.5.2 Financial Assurance and Recordkeeping for Decommissioning ........... 8-7

31 8.6 Item 6: Purposes For Which Licensed Material Will Be Used ........................... 8-9

32 8.6.1 Distribution and Redistribution of Sealed and 

33 Unsealed Materials ............................................................................. 8-10

34 8.6.2 Preparation of Radiopharmaceuticals ................................................. 8-13

35 8.6.3 Sealed Sources for Calibration and Checks and Possession of 

36 Discrete Sources of Radium-226 and Depleted Uranium ................... 8-14

37 8.6.4 Service Activities ................................................................................. 8-14

38 8.7 Item 7: Individual(s) Responsible for Radiation Safety Program and 

39 Their Training and Experience ............................................................ 8-15

40 8.7.1 Radiation Safety Officer ...................................................................... 8-15

41 8.7.2 Authorized Nuclear Pharmacist (ANP) ................................................ 8-17

42 8.7.3 Authorized Users (AU) ........................................................................ 8-20
viii 

1 8.8 Item 8: Training for Individuals Working In or Frequenting 

2 Restricted Areas .................................................................................. 8-22

3 8.8.1 Occupationally Exposed Workers And Ancillary Personnel ................ 8-22

4 8.8.2 Personnel Involved in Hazardous Materials Package 

5 Preparation and Transport .................................................................. 8-24

6 8.8.3 Instruction for Supervised Individuals Preparing 

7 Radiopharmaceuticals ......................................................................... 8-25

8 8.9 Item 9: Facilities and Equipment ..................................................................... 8-26

9 8.9.1 Facilities and Equipment for Radiopharmacies ................................... 8-26

10 8.9.2 Facilities and Equipment for PET Radiopharmacies ........................... 8-29

11 8.10 Item 10: Radiation Safety Program ................................................................. 8-32

12 8.10.1 Audit and Review of Program ............................................................ 8-32

13 8.10.2 Radiation Monitoring Instruments ...................................................... 8-33

14 8.10.3 Material Receipt and Accountability ................................................... 8-35

15 8.10.4 Occupational Dose ............................................................................ 8-40

16 8.10.5 Public Dose ........................................................................................ 8-43

17 8.10.6 Safe Use of Radionuclides and Emergency Procedures ................... 8-45

18 8.10.7 Surveys .............................................................................................. 8-49

19 8.10.8 Dosage Measurement Systems ......................................................... 8-52

20 8.10.9 Transportation .................................................................................... 8-54

21 8.10.10 Minimization of Contamination .......................................................... 8-55

22 8.10.11 Radioactive Drug Labeling for Distribution ........................................ 8-56

23 8.10.12 Radioactive Drug Shielding for Distribution ...................................... 8-57

24 8.10.13 Leak Tests ........................................................................................ 8-57

25 8.10.14 Security Program for Category 1 and Category 2 

26 Radioactive Material ......................................................................... 8-58

27 8.11 Item 11: Waste Management .......................................................................... 8-60

28 8.11.1 Returned Wastes From Customers ................................................... 8-64

29 8.12 Item 12: License Fees ..................................................................................... 8-65

30 8.13 Item 13: Certification ....................................................................................... 8-65

31 9 LICENSE AMENDMENTS AND RENEWALS ............................................................... 9-1

32 9.1 Timely Notification of Transfer of Control ........................................................... 9-1

33 10 APPLICATIONS FOR EXEMPTIONS ......................................................................... 10-1

34 11 TERMINATION OF ACTIVITIES ................................................................................. 11-1

35 APPENDICES 

36 APPENDIX A UNITED STATES NUCLEAR REGULATORY COMMISSION 

37 FORM 313 ............................................................................................. A–1 

38 APPENDIX B SUGGESTED FORMAT FOR PROVIDING INFORMATION 

39 REQUESTED IN ITEMS 5 THROUGH 11 OF NRC FORM 313 ........... B–1 

40 APPENDIX C CHECKLIST FOR LICENSE APPLICATION ........................................ C–1 

41 APPENDIX D FORMATS FOR DOCUMENTING TRAINING AND 

42 EXPERIENCE FOR INDIVIDUALS RESPONSIBLE 

43 FOR RADIATION PROTECTION PROGRAM ...................................... D–1 

44 APPENDIX E TYPICAL DUTIES AND RESPONSIBILITIES OF THE 

45 RADIATION SAFETY OFFICER ........................................................... E–1 
ix 

1 APPENDIX F SUGGESTED COMMERCIAL RADIOPHARMACY 

2 AUDIT CHECKLIST .............................................................................. F–1 

3 APPENDIX G GENERAL RADIATION MONITORING INSTRUMENT 

4 SELECTION GUIDELINES AND RADIATION INSTRUMENT 

5 CALIBRATION GUIDELINES ............................................................. G–1 

6 APPENDIX H PUBLIC DOSE ...................................................................................... H–1 

7 APPENDIX I MODEL LEAK TEST PROGRAM .......................................................... I–1 

8 APPENDIX J U.S. DEPARTMENT OF TRANSPORTATION REGULATIONS .......... J–1 

9 APPENDIX K MODEL PERSONNEL TRAINING PROGRAM .................................... K–1 

10 APPENDIX L DOSE CALIBRATOR TESTING GUIDANCE ....................................... L–1 

11 APPENDIX M MATERIAL RECEIPT AND ACCOUNTABILITY ................................. M–1 

12 APPENDIX N GENERAL TOPICS FOR SAFE USE OF RADIONUCLIDES 

13 AND MODEL EMERGENCY PROCEDURES ...................................... N–1 

14 APPENDIX O RADIATION SURVEY GUIDELINES ................................................... O–1 

15 APPENDIX P MODEL PROCEDURE FOR RETURN OF RADIOACTIVE 

16 WASTES FROM CUSTOMERS ............................................................ P–1 

17 APPENDIX Q NRC INCIDENT NOTIFICATIONS ....................................................... Q–1 

18 APPENDIX R CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

19 INFORMATION FROM PUBLIC DISCLOSURE 

20 (UNDER 10 CFR 2.390) ........................................................................ R–1 

21 APPENDIX S SAFETY CULTURE STATEMENT OF POLICY ................................... S–1 

xi 

1 FIGURES 

2 2-1 U.S. Map: Locations of NRC Offices and Agreement States ........................................ 2-1 

3 8-1 Location of Use .............................................................................................................. 8-3 

4 8-2 Typical Radiopharmacy Diagram ................................................................................. 8-29 

5 8-3 Typical PET Radiopharmacy Diagram ......................................................................... 8-31 

6 8-4 Annual Dose Limits for Adult Radiation Workers ......................................................... 8-41 

7 8-5 Use of Appropriate Shielding in a Fume Hood ............................................................. 8-46 

8 8-6 Types of Surveys ......................................................................................................... 8-49 

9 8-7 Personnel Surveys ....................................................................................................... 8-50 

10 8-8 Returned Waste ........................................................................................................... 8-65 

11 E–1 Typical Duties and Responsibilities of the RSO ............................................................ E–3 

12 N–1 Storage of Food and Drink ............................................................................................ N–2 

13 TABLES 

14 2-1 Who Regulates the Activity? .......................................................................................... 2-2 

15 3-1 Traits of a Positive Safety Culture .................................................................................. 3-3 

16 8-1 Package Monitoring Requirements .............................................................................. 8-38 

17 8-2 Record Maintenance .................................................................................................... 8-39 

18 8-3 Guidance on Personnel Monitoring and Bioassay ....................................................... 8-43 

19 D–1 Authorized User or Radiation Safety Officer Training and Experience in 

20 Handling Radionuclides ................................................................................................ D–1 

21 H–1 Standard Occupancy Factors ....................................................................................... H–3 

22 Q–1 Typical Notification Required for Radiopharmacy Licensees ....................................... Q–1 

xiii 

1 ACKNOWLEDGMENTS 

2 The working group would like to thank the staff in the regional offices of the U.S. Nuclear 

3 Regulatory Commission (NRC) and all of the States who provided comments and technical 

4 information that assisted in the development of this report. 

5 The working group would like to thank the staff in the Headquarters and regional offices of the 

6 NRC and all of the Agreement States who provided comments and technical information that 

7 assisted in the development of this report. 

8 The Participants for this Revision 

9 Elliott, Robin L. 

10 Gattone, Robert G. 

11 Graham, Charlene 

12 Katanic, Janine F. 

13 Roldan-Otero, Lizette 

14 Thompson, Thomas

xv 

1 ABBREVIATIONS 

2 ACMUI Advisory Committee on the Medical Uses of Isotopes 

3 ADAMS Agencywide Documents Access Management System 

4 AEA Atomic Energy Act 

5 ALARA as low as is reasonably achievable 

6 ALI Annual Limit On Intake 

7 ANP Authorized Nuclear Pharmacist 

8 ANSI American National Standards Institute 

9 AU Authorized User 

10 Bq becquerel 

11 CEDE Committed Effective Dose Equivalent 

12 CFR Code of Federal Regulations 

13 Ci curie 

14 cm centimeter 

15 cpm counts per minute 

16 DAC Derived Air Concentration 

17 DDE Deep Dose Equivalent 

18 DIS Decay In Storage 

19 DFP decommissioning funding plan 

20 DOT U.S. Department of Transportation 

21 dpm disintegrations per minute 

dpm/cm2 22 dpm per square cm 

23 DU depleted uranium 

24 EPAct Energy Policy Act of 2005 

25 FA Financial Assurance 

26 FDA U.S. Food and Drug Administration 

27 FR Federal Register 

28 GM Geiger Mueller 

29 GBq Gigabecquerel 

30 GL Generic Letter 

31 IN Information Notice 

32 IP Inspection Procedure 

33 LLEA Local Law Enforcement Agencies 

34 LSC Liquid Scintillation Counter 

35 mCi millicurie 

36 mGy milligray 

37 MDA Minimum Detectable Activity 

38 MOU Memorandum Of Understanding 

39 mR milliroentgen 

40 mrem millirem 

41 mrem/hr mrem per hour 

42 mSv millisievert 

43 mSv/hr mSv per hour 

44 NaI sodium iodide 

45 NARM Naturally Occurring And Accelerator Produced Radioactive Material 

46 NCRP National Council on Radiation Protection and Measurements 

47 NIST National Institute of Standards and Technology 

48 NMSS Office Of Nuclear Material Safety And Safeguards 

49 NRC U.S. Nuclear Regulatory Commission 

50 NSTS National Source Tracking System 
xvi 

1 NSTTR National Source Tracking Transaction Reports 

2 NVLAP National Voluntary Laboratory Accreditation Program 

3 OSL Optically Stimulated Luminescence (Dosimeter) 

4 PET Positron Emission Tomography 

5 PII Personally Identifiable Information 

6 R roentgen 

7 RG Regulatory Guide 

8 RIS Regulatory Issue Summary 

9 RQ Reportable Quantity 

10 RSO Radiation Safety Officer 

11 SDE Shallow Dose Equivalent 

12 SI International System Of Units (abbreviated SI from the French, Le Système 

13 Internationale d’Unités) 

14 SSD Sealed Source and Device 

15 Sv sievert 

16 TEDE Total Effective Dose Equivalent 

17 TI Transportation Index 

18 TLD Thermoluminescent Dosimeters 

19 U.S.C. United States Code 
1-1 

1 1 PURPOSE OF REPORT 

2 This NUREG provides guidance to an applicant applying for a commercial radiopharmacy 

3 license, and provides the U.S. Nuclear Regulatory Commission (NRC) staff with the criteria for 

4 evaluating such applications. Within this document, the terms “byproduct material,” 

5 “licensed material,” and “radioactive material” are used interchangeably. In addition, the 

6 phrases or terms, “commercial radiopharmacy,” “radiopharmacy,” and “nuclear pharmacy” 

7 are used interchangeably. 

8 Commercial radiopharmacy licenses are those licenses issued by the NRC, pursuant to 

9 Title 10 of the Code of Federal Regulations (10 CFR) Part 30, “Rules of General Applicability to 

10 Domestic Licensing of Byproduct Material,” and 10 CFR 32.72, “Manufacture, preparation, or 

11 transfer for commercial distribution of radioactive drugs containing byproduct material for 

12 medical use under 10 CFR Part 35.” Within this document, preparation includes the making of 

13 radiopharmaceuticals from reagent kits (e.g., technetium-99m macroaggregated albumin), and 

14 from raw materials (e.g., the compounding of radioiodine capsules for diagnostic and 

15 therapeutic medical use or Positron Emission Tomography (PET) radiopharmaceuticals for 

16 medical use). Commercial radiopharmacies may also be authorized to transfer for commercial 

17 distribution in vitro test kits described in 10 CFR 31.11, “General license for use of byproduct 

18 material for certain in vitro clinical or laboratory testing,” radiopharmaceuticals to licensees 

19 authorized to possess them for other than human medical use (e.g., veterinary medicine and 

20 research licensees), and radiochemicals to those licensees authorized to possess them, 

21 pursuant to 10 CFR Part 30. In addition, 10 CFR Part 30 authorizes radiopharmacies to 

22 redistribute (transfer) sealed sources for calibration and medical use initially distributed by a 

23 manufacturer licensed pursuant to 10 CFR 32.74, “Manufacture and distribution of sources or 

24 devices containing byproduct material for medical use.” 

25 Specific guidance for applicants requesting the production of radioactive material using an 

26 accelerator (e.g., PET radiopharmacies) is included in NUREG-1556, Volume 21, 

27 “Program-Specific Guidance About Possession Licenses for Production of Radioactive Materials 

28 Using an Accelerator.” 

29 Note that this NUREG should be used for the activities that take place after the radiochemical is 

30 produced, which would include compounding the radiochemical to a radiopharmaceutical. Also, 

31 specific guidance for applicants requesting authorization to manufacture and initially distribute 

32 molybdenum-99/technetium-99m generators, in vitro kits, radiochemicals and sealed sources is 

33 included in NUREG-1556, Volume 12, “Program-Specific Guidance About Possession Licenses 

34 for Manufacturing and Distribution,” and is not within the scope of this guidance for commercial 

35 radiopharmacies. These activities require specific NRC or Agreement State authorization and 

36 must be included on a specific license. 

37 Furthermore, specific guidance for applicants requesting authorization to manufacture, 

38 distribute, and redistribute radioactive drugs to persons exempt from licensing (e.g., carbon-14 

39 tagged urea) is included in NUREG-1556, Volume 8, “Program-Specific Guidance About 

40 Exempt Distribution Licenses,” and also is not within the scope of this guidance. These 

41 activities require specific NRC authorization and require the issuance of a separate license for 

42 exempt distribution. Chapter 8, “Contents of an Application,” of this NUREG identifies the 

43 information needed to complete NRC Form 313, “Application for Materials License” 

44 (see Appendix A of this NUREG), for the use of byproduct materials in commercial 

45 radiopharmacies. The Office of Management and Budget (OMB) has approved the information 

46 collection requirements in 10 CFR Part 30, “Rules of General Applicability to Domestic 
1-2 

1 Licensing of Byproduct Material,” and NRC Form 313 under the OMB Clearance 

2 Nos. 3150-0017 and 3150-0120, respectively. 

3 The format within this document for each item of technical information is as follows: 

4  Regulations—references the regulations applicable to the item 

5  Criteria—outlines the criteria used to evaluate the applicant’s response 

6  Discussion—provides additional information about the topic 

7  Response from Applicant—provides suggested response or responses, offers the option 

8 of an alternative reply, or indicates that no response is needed on that topic during the 

9 licensing process 

10 Notes and References are self-explanatory and may not be found for each item on 

11 NRC Form 313. 

12 NRC Form 313 does not have sufficient space for applicants to provide full responses to 

13 Items 5 through 11, as indicated on the form. Applicants should address those items on 

14 separate sheets of paper and submit them along with the completed NRC Form 313. For the 

15 convenience and streamlined handling of applications for commercial radiopharmacy licenses in 

16 the new materials licensing process, Appendix B of this NUREG, “Suggested Format for 

17 Providing Information Requested in Items 5 through 11 of NRC Form 313,” may be used to 

18 provide supporting information. 

19 Appendix C of this NUREG is a checklist that NRC staff uses to review applications and that 

20 applicants may use to check for completeness. Appendices D through P contain additional 

21 information on various radiation safety topics, including model procedures. Appendix Q of this 

22 NUREG includes a table (Table Q–1) of NRC incident notification and reporting requirements 

23 applicable to commercial radiopharmacies. 

24 In this document, “dose” or “radiation dose” means either absorbed dose, dose equivalent, 

25 effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or 

26 total effective dose equivalent (TEDE), as defined in 10 CFR Part 20, “Standards for Protection 

27 Against Radiation.” Rem and its International System of Units (SI) equivalent, sievert (Sv) 

28 (1 rem = 0.01 Sv), are used to describe units of radiation exposure or dose. These are used 

29 because 10 CFR Part 20 sets dose limits in terms of rem, rather than rad or roentgen (R). 

30 When the radioactive material emits beta and gamma rays, for practical reasons, 1 R is 

31 assumed to equal 1 rad, which is assumed to equal 1 rem. For alpha and neutron emitting 

32 radioactive material, 1 rad is not equal to 1 rem. Determination of dose equivalent (rem) from 

33 absorbed dose (rad) from alpha particles and neutrons requires the use of an appropriate 

34 quality factor (Q) value. These Q values are used to convert absorbed dose (rad) to dose 

35 equivalent (rem); Tables 1004(b).1 and 1004(b).2 in 10 CFR 20.1004, “Units of radiation dose,” 

36 address the Q values for alpha and neutron particles.
2-1 

1 2 AGREEMENT STATES 

2 Certain States, called Agreement States (see Figure 2-1), have entered into agreements with 

3 the U.S. Nuclear Regulatory Commission (NRC) that give them the authority to license and 

4 inspect byproduct, source, and special nuclear materials in quantities not sufficient to form a 

5 critical mass, which are used or possessed within their borders. Any applicant, other than a 

6 Federal entity, who wishes to possess or use licensed material in one of these Agreement 

7 States should contact the responsible officials in that State for guidance on preparing an 

8 application. These applications should be filed with State officials, not with the NRC. In areas 

9 under exclusive Federal jurisdiction within an Agreement State, NRC continues to be the 

10 regulatory authority. 

Figure 2-1. U.S. Map: Locations of NRC Offices and Agreement States 

 
2-2 

1 In the special situation of work at federally controlled sites in Agreement States, it is necessary 

2 to ascertain the jurisdictional status of the area to determine whether the NRC or the Agreement 

3 State has regulatory authority. These areas can also include Tribal lands of federally 

recognized Indian Tribes.2 4 

5 The NRC has regulatory authority over land determined to be “exclusive Federal jurisdiction,” 

6 while the Agreement State may have jurisdiction over nonexclusive Federal jurisdiction land. 

7 Applicants are responsible for determining, in advance, the jurisdictional status of the specific 

8 areas where they plan to conduct licensed operations. Additional guidance on determining 

9 jurisdictional status is found in the Office of Nuclear Material Safety and Safeguards (NMSS) 

10 procedures in the State Agreement series, SA-500, “Jurisdiction Determination,” which is 

11 available at https://scp.nrc.gov. Once on the Web site, use the link for “NMSS Procedures” in 

12 the left-hand column under “Resources & Tools.” 

13 Table 2-1 provides a quick way to evaluate whether the NRC or an Agreement State has 

14 regulatory authority. 

Table 2-1. Who Regulates the Activity?

Applicant and Proposed Location of Work 

Regulatory 

Agency 

Federal agency, regardless of location (except that the U.S. Department of 

Energy and, under most circumstances, its prime contractors are exempt 

from licensing, in accordance with 10 CFR 30.12, “Persons using byproduct 

material under certain U.S. Department of Energy and U.S. Nuclear 

Regulatory Commission contracts;” also, see 10 CFR 40.11, and/or 

10 CFR 70.11, if applicable). 

NRC 

Non-Federal entity in non-Agreement State, District of Columbia, 

U.S. territory or possession, or in offshore Federal waters NRC 

Federally recognized Indian Tribe or Tribal member on Indian Tribal land NRC 

Non-Federal entity on federally recognized Indian Tribal land NRC3

Federally recognized Indian Tribe or Tribal member outside of Indian Tribal 

land in Agreement State. Agreement State

 

2

For the purposes of this guidance, an “Indian Tribe” is defined as an Indian or Alaska Native tribe, band, nation, 

pueblo, village, or community that the Secretary of the Interior acknowledges to exist as an Indian Tribe pursuant to 

the Federally Recognized Indian Tribe List Act of 1994. A list of federally recognized tribes is available at 

www.bia.gov. 

3

The NRC can exercise jurisdiction as the regulatory authority on Tribal land of a federally recognized Indian Tribe. 

Section 274b. agreements do not give States the authority to regulate nuclear material in these areas. However, 

there may be States that exercise regulatory authority over these areas, based on treaties or agreements with 

specific tribes. Companies owned or operated by federally recognized Indian Tribe members or non-Indians that 

wish to possess or use licensed material on Tribal lands should contact the appropriate NRC regional office to 

determine the jurisdictional status of the Tribal lands and identify the appropriate regulatory agency for licensing 

and reciprocity.
2-3 

Table 2-1. Who Regulates the Activity?

Applicant and Proposed Location of Work 

Regulatory 

Agency 

Non-Federal entity in Agreement State Agreement 

State4

Non-Federal entity in Agreement State at federally controlled site not subject 

to exclusive Federal jurisdiction 

Agreement 

State4

Non-Federal entity in Agreement State at federally controlled site subject to 

exclusive Federal jurisdiction NRC 

Non-Federal entity in Agreement State using radioactive materials 

(except industrial radiography) directly connected with 10 CFR Part 50 or 52 

reactor operations or needed during the construction and preoperational 

phases of a reactor. 

NRC 

Non-Federal entity in Agreement State using radioactive materials not

directly connected with 10 CFR Part 50 or 52 reactor operations or needed 

during the construction and preoperational phases of a reactor. 

Agreement 

State4

1 Reference: A current list of Agreement States (including names, addresses, and telephone 

2 numbers of responsible officials) is available at the NMSS public Web site at https://scp.nrc.gov. 

3 A request for the list can also be made to an NRC regional office.

 

4

Section 274m. of the Atomic Energy Act (AEA) withholds to the NRC regulatory authority over radioactive materials 

covered under the Section 274b. agreements when the activity can affect the Commission’s authority to protect the 

common defense and security, to protect restricted data, or guard against the loss or diversion of special nuclear 

material. (This is an uncommon situation that NRC usually evaluates on a case-by-case basis.) Individuals or 

companies wishing to possess or use licensed material should contact the licensee to determine the jurisdictional 

status for specific AEA radioactive materials they intend to possess or use. 

3-1 

1 3 MANAGEMENT RESPONSIBILITY 

2 The U.S. Nuclear Regulatory Commission (NRC) recognizes that effective management of 

3 radiation safety programs is vital to achieving safe, secure, and compliant operations. 

4 Consistent compliance with NRC regulations provides reasonable assurance that licensed 

5 activities will be conducted safely and that effective management will result in increased safety, 

6 security, and compliance. 

“Management,” as used in this volume, refers to the processes for conduct and control of a 

radiation safety program and to the individuals who are responsible for those processes and 

who have authority to provide necessary resources to achieve regulatory compliance. 

7 3.1 Commitments and Responsibilities 

8 Pursuant to Title 10 of the Code of Federal Regulations (10 CFR) 30.32(c), each application 

9 must be signed by the applicant or licensee or a person duly authorized to act for and on behalf 

10 of the applicant or licensee. If it is not clear whether the application was signed by someone 

11 duly authorized to act for and on behalf of the applicant or licensee, NRC license reviewers may 

12 ask for additional assurances that the individual who signed the application is duly authorized to 

13 act for and on the behalf of the applicant or licensee. The signature on an application 

14 acknowledges the licensee’s commitments and responsibilities, including the following: 

15  to ensure radiation safety, security, and control of radioactive materials and compliance 

16 with regulations 

17  to ensure that radiation safety records and all information provided to the NRC are 

18 complete and accurate (10 CFR 30.9, “Completeness and accuracy of information”) 

19  to affirm the licensee’s knowledge about the contents of the license and application 

20  to comply with NRC and U.S. Department of Transportation (DOT) regulations, 

21 the licensee’s operating, emergency, and security procedures, and NRC 

22 license commitments 

23  to provide adequate resources (including space, equipment, personnel, time, and, if 

24 needed, contractors) to the radiation protection program to ensure that the public 

25 and workers are protected from radiation hazards and compliance with regulations 

26 is maintained 

27  to report defects, noncompliances, or reportable events in accordance with regulations 

28  to select and assign a qualified individual to serve as the radiation safety officer (RSO) 

29 for licensed activities and confirmation that the RSO has independent authority to 

30 stop unsafe operations and will be given sufficient time to fulfill radiation safety duties 

31 and responsibilities 

32  to ensure that radiation workers have adequate training 

33  to prevent discrimination of employees engaged in protected activities 

34 (10 CFR 30.7, “Employee protection”) 
3-2 

1  to provide information to employees about the employee protection and deliberate 

2 misconduct provisions in 10 CFR 30.7, “Employee protection,” and 10 CFR 30.10, 

3 “Deliberate misconduct” 

4  to obtain NRC’s prior written consent before transferring control of the license 

5 (see Section 9.1, “Timely Notification of Transfer of Control,” of this NUREG) 

6  to notify the appropriate NRC regional administrator, in writing, immediately following the 

7 filing of petition for voluntary or involuntary bankruptcy [10 CFR 30.34(h)], as discussed 

8 further in Section 8.2.1, “Notification of Bankruptcy Proceedings,” of this NUREG. 

9 For information on NRC inspection, investigation, enforcement, and other compliance programs, 

10 see the current version of the NRC’s Enforcement Policy and Inspection Procedures available in 

11 the NRC’s online library, under “Document Collections,” at http://www.nrc.gov/reading-rm.html. 

12 3.2 Safety Culture 

13 Individuals and organizations performing regulated activities are expected to establish and 

14 maintain a positive safety culture commensurate with the safety and security significance of 

15 their activities and the nature and complexity of their organizations and functions. This applies 

16 to all licensees, certificate holders, permit holders, authorization holders, holders of quality 

17 assurance program approvals, vendors and suppliers of safety-related components, and 

18 applicants for a license, certificate, permit, authorization, or quality assurance program approval, 

19 subject to NRC authority. 

20 “Nuclear safety culture” is defined in the NRC’s Safety Culture Policy Statement (76 FR 34773; 

21 June 14, 2011) as “the core values and behaviors resulting from a collective commitment by 

22 leaders and individuals to emphasize safety over competing goals to ensure protection of 

23 people and the environment.” Individuals and organizations performing regulated activities bear 

24 the primary responsibility for safely handling and securing these materials. Experience has 

25 shown that certain personal and organizational traits are present in a positive safety culture. A 

26 trait, in this case, is a pattern of thinking, feeling, and behaving that emphasizes safety, 

27 particularly in goal-conflict situations (e.g., production versus safety, schedule versus safety, 

28 and cost of the effort versus safety). Refer to Table 3-1 for the traits of a positive safety culture 

29 from NRC’s safety culture policy statement. 

30 Organizations should ensure that personnel in the safety and security sectors have an 

31 appreciation for the importance of each, emphasizing the need for integration and balance to 

32 achieve both safety and security in their activities. Safety and security activities are closely 

33 intertwined. While many safety and security activities complement each other, there may be 

34 instances in which safety and security interests create competing goals. It is important that 

35 consideration of these activities be integrated so as not to diminish or adversely affect either; 

36 thus, mechanisms should be established to identify and resolve these differences. A safety 

37 culture that accomplishes this would include all nuclear safety and security issues associated 

38 with NRC-regulated activities. 

39 The NRC, as the regulatory agency with an independent oversight role, reviews the 

40 performance of individuals and organizations to determine compliance with requirements and 

41 commitments through its existing inspection and assessment processes. However, NRC’s 

42 safety culture policy statement and traits are not incorporated into the regulations. Safety 

43 culture traits may be inherent to an organization’s existing radiation safety practices and 
3-3 

1 programs. For instance, radiopharmacy licensees that handle unsealed materials must perform 

2 surveys to identify skin contamination so that prompt actions may be taken to minimize the dose 

3 to the individual and reduce the spread of the contamination. The need to perform the 

4 personnel surveys may correspond with the safety culture trait specified in Table 3-1 as 

5 “Work Processes” (the process of planning and controlling work activities is implemented so that 

6 safety is maintained). However, licensees should be aware that this is just an example, and 

7 should consider reviewing their radiation safety programs in order to develop and implement 

8 a safety culture commensurate with the nature and complexity of their organizations 

9 and functions. 

10 Refer to Appendix S of this NUREG for the NRC’s Safety Culture Policy Statement. More 

11 information on NRC activities relating to safety culture can be found at 

12 http://www.nrc.gov/about-nrc/safety-culture.html. 

Table 3-1. Traits of a Positive Safety Culture 

Leadership Safety Values

and Actions

Problem Identification and 

Resolution Personal Accountability

Leaders demonstrate a 

commitment to safety in their 

decisions and behaviors. 

Issues potentially impacting 

safety are promptly 

identified, fully evaluated, 

and promptly addressed and 

corrected commensurate 

with their significance. 

All individuals take personal 

responsibility for safety. 

Work Processes Continuous Learning

Environment for Raising 

Concerns

The process of planning and 

controlling work activities is 

implemented so that safety 

is maintained. 

Opportunities to learn about 

ways to ensure safety are 

sought out and implemented. 

A safety conscious work 

environment is maintained 

where personnel feel free to 

raise safety concerns without 

fear of retaliation, 

intimidation, harassment, or 

discrimination. 

Effective Safety 

Communications

Respectful Work 

Environment Questioning Attitude

Communications maintain a 

focus on safety. 

Trust and respect permeate 

the organization. 

Individuals avoid 

complacency and 

continuously challenge 

existing conditions and 

activities in order to identify 

discrepancies that might 

result in error or 

inappropriate action. 

4-1 

1 4 APPLICABLE REGULATIONS 

2 It is the applicant’s or licensee’s responsibility to obtain and have available up-to-date copies of 

3 applicable regulations, to read and understand the requirements of each of these regulations, 

4 and to comply with each applicable regulation. The following parts of Title 10 of the Code of 

5 Federal Regulations (10 CFR) contain regulations applicable to radiopharmacy. Some of these 

6 parts are specific to one type of license, while others are general and will apply to many, if not 

7 all, licensees. 

8 The current versions of these 10 CFR regulations can be found under the “Basic References” 

9 link at the NRC’s online library at http://www.nrc.gov/reading-rm.html. For viewing in a browser, 

10 the following list includes direct links to the rules: 

11  10 CFR Part 2 “Agency Rules of Practice and Procedure” 

12  10 CFR Part 19 “Notices, Instructions, and Reports to Workers: Inspection 

13 and Investigations” 

14  10 CFR Part 20 “Standards for Protection Against Radiation” 

15  10 CFR Part 21 “Reporting of Defects and Noncompliance” 

16  10 CFR Part 30 “Rules of General Applicability to Domestic Licensing of 

17 Byproduct Material” 

18  10 CFR Part 31 “General Domestic Licenses for Byproduct Material” 

19  10 CFR Part 32 “Specific Domestic Licenses to Manufacture or Transfer Certain 

20 Items Containing Byproduct Material” 

21  10 CFR Part 37 “Physical Protection of Category 1 and Category 2 Quantities of 

22 Radioactive Material” 

23  10 CFR Part 40 “Domestic Licensing of Source Material” 

24  10 CFR Part 70 “Domestic Licensing of Special Nuclear Material” 

25  10 CFR Part 71 “Packaging and Transportation of Radioactive Material” 

26  10 CFR Part 110 “Export and Import of Nuclear Equipment and Material” 

27  10 CFR Part 170 “Fees for Facilities, Materials, Import and Export Licenses, and 

28 Other Regulatory Services Under the Atomic Energy Act of 1954, 

29 as Amended” 

30  10 CFR Part 171 “Annual Fees for Reactor Licenses and Fuel Cycle Licenses and 

31 Materials Licenses, Including Holders of Certificates of 

32 Compliance, Registrations, and Quality Assurance Program 

33 Approvals and Government Agencies Licensed by the NRC” 
4-2 

1 Copies of these documents may be obtained by calling the Government Printing Office 

2 Customer Contact Center toll-free at 866-512-1800, in Washington, DC; calling 202-512-1800; 

3 or ordering online at http://bookstore.gpo.gov. 

4 In addition, 10 CFR Parts 1 through 199 can be found on the NRC’s Web site at 

5 http://www.nrc.gov/reading-rm/doc-collections/ under “Regulations (10 CFR).” 

6 The U.S. Nuclear Regulatory Commission (NRC) regulations can also be accessed from the 

7 “NRC Library” link on the NRC’s public Web site at http://www.nrc.gov. Regulations are 

8 periodically amended, and the NRC (as well as all other Federal agencies) is required to publish 

9 notice of such amendments in the Federal Register. 
5-1 

1 5 HOW TO FILE 

2 5.1 Application Preparation 

3 Applicants for a materials license should do the following: 

4  Use the most recent guidance in preparing an application. 

5  Complete U.S. Nuclear Regulatory Commission (NRC) Form 313 (Appendix A of this 

6 NUREG), Items 1 through 4, 12, and 13, on the form itself. A link to the form is available 

7 at http://www.nrc.gov/reading-rm/doc-collections/forms/. 

8  Complete NRC Form 313, Items 5 through 11, on supplementary pages or use 

9 Appendix A of this NUREG. 

10  Provide sufficient detail for the NRC to determine that the equipment, facilities, training, 

11 experience, and radiation safety program are adequate to protect health and safety and 

12 minimize danger to life and property. 

13  For each separate sheet other than NRC Form 313 and Appendix A pages, as 

14 applicable, identify and cross-reference submitted information to the item number on the 

15 application or the topic to which it refers. 

16  Avoid submitting proprietary information and personally identifiable information. If 

17 submitted, proprietary, personal privacy, security-related, and other sensitive information 

18 should be clearly identified according to Title 10 of the Code of Federal Regulations

19 (10 CFR) Part 2.390, “Public inspections, exemptions, requests for withholding” 

20 (see Chapter 6, “Identifying and Protecting Sensitive Information”). 

21 5.2 Where to File 

22 Applicants wishing to possess or use licensed material in any State, U.S. territory, or 

23 U.S. possession subject to NRC jurisdiction must file an application with the NRC regional office 

24 for the locale in which the material will be possessed or used. Figure 2-1 identifies the NRC’s 

25 four regional offices and their respective areas for licensing purposes and the Agreement 

26 States. Note that all materials applications are submitted to Regions I, III, or IV. All applicants 

27 for materials licenses located in the Region II geographical area should send their applications 

28 to Region I. 

29 In general, applicants wishing to possess or use licensed material in Agreement States must file 

30 an application with the Agreement State and not with the NRC. However, if work will be 

31 conducted at federally controlled sites, or federally recognized Indian Tribal lands, in Agreement 

32 States, applicants must first determine the jurisdictional status of the land in order to determine 

33 whether the NRC or the Agreement State has regulatory authority. See Chapter 2, “Agreement 

34 States,” for additional information. 
5-2 

1 5.3 Paper Applications 

2 Paper applications received by the NRC are scanned through an optical character reader and 

3 converted to an electronic format. To ensure a smooth transfer to an electronic format, 

4 applicants should do the following: 

5  Submit all documents, typed, on 81⁄2 × 11-inch or legal-sized paper that will feed easily 

6 into a document scanner. 

7  Choose typeface designs that are sans serif, such as Arial, Helvetica, or Futura. 

8  Use 11-point or larger font. 

9  Avoid stylized characters, such as script or italics. 

10  Ensure that the print is clear and sharp. 

11  Ensure that there is high contrast between the ink and paper (black ink on white paper 

12 is best). 

Applications must be signed by the applicant, licensee, or a person duly authorized, as 

required by 10 CFR 30.32(c) (see Section 8.13, “Certification”). 

13 5.4 Electronic Applications 

14 Applications may be submitted in electronic form via the NRC’s Electronic Information Exchange 

15 or CD-ROM. Detailed guidance on making electronic submissions can be obtained by visiting 

16 the NRC’s Web site at http://www.nrc.gov/site-help/e-submittals.html. The guidance discusses,

17 among other topics, the formats the NRC can accept, the use of electronic signatures, and the 

18 treatment of nonpublic information.
6-1 

1 6 IDENTIFYING AND PROTECTING SENSITIVE INFORMATION 

2 All licensing applications, except for portions containing sensitive information, will be made 

3 available for review in the U.S. Nuclear Regulatory Commission (NRC) Public Document Room 

4 and electronically at the NRC Library. For more information on the NRC Library, visit 

5 www.nrc.gov. 

6 The applicant or licensee should identify, mark, and protect sensitive information against 

7 unauthorized disclosure to the public. License applications that contain sensitive information 

8 should be marked as indicated in the list that follows in accordance with Title 10 of the Code of 

9 Federal Regulations (10 CFR) 2.390 before the information is submitted to the NRC. Key 

10 examples are as follows: 

11  Proprietary Information and Trade Secrets: If it is necessary to submit proprietary 

12 information or trade secrets, follow the procedure in 10 CFR 2.390(b). Failure to follow 

13 this procedure could result in disclosure of the proprietary information to the public or 

14 substantial delays in processing the application. Appendix R of this NUREG provides a 

15 checklist for requests for withholding proprietary information from public disclosure. 

16  Personally Identifiable Information: Personally identifiable information (PII) about 

17 employees or other individuals should not be submitted unless specifically requested by 

18 the NRC. Examples of PII are social security number, home address, home telephone 

19 number, date of birth, and radiation dose information. If PII is submitted, a cover letter 

20 should clearly state that the attached documents contain PII and the top of every page of 

21 a document that contains PII should be clearly marked as follows: “Privacy Act 

22 Information—Withhold under 10 CFR 2.390.” For further information, see Regulatory 

23 Issue Summary (RIS) 2007-04, “Personally Identifiable Information Submitted to the 

24 U.S. Nuclear Regulatory Commission,” dated March 9, 2007, and Information Notice (IN) 

25 2013-22, “Recent Licensing Submittals Containing Personally Identifiable Information,” 

26 dated November 15, 2013, which can be found on the NRC’s Generic Communications 

27 Web page under “Regulatory Issue Summaries” and “Information Notices,” respectively, 

28 at http://www.nrc.gov/reading-rm/doc-collections/gen-comm/. 

29  Security-Related Information: Following the events of September 11, 2001, the NRC 

30 changed its procedures to avoid the release of information that terrorists could use to 

31 plan or execute an attack against facilities or citizens in the U.S. As a result, certain 

32 types of information are no longer routinely released and are treated as sensitive 

33 unclassified information. For example, certain information about the quantities and 

34 locations of radioactive material at licensed facilities and associated security measures 

35 are no longer released to the public. Therefore, a cover letter should clearly state that 

36 the attached documents contain sensitive security-related information and the top of 

37 every page of a document that contains such information should be clearly marked: 

38 “Security Related Information—Withhold under 10 CFR 2.390.” For the pages having 

39 security-related sensitive information, an additional marking should be included 

40 (e.g., an editorial note box) adjacent to that material. For further information, see RIS 

41 2005-31, “Control of Security-Related Sensitive Unclassified Non-Safeguards 

42 Information Handled by Individuals, Firms, and Entities Subject to NRC Regulation of the 

43 Use of Source, Byproduct, and Special Nuclear Material,” dated December 22, 2005, 

44 which can be found on the NRC’s Generic Communications Web page under 

45 “Regulatory Issue Summaries” at http://www.nrc.gov/reading-rm/doc-collections/gen-
6-2 

1 comm/. Additional information on procedures and any updates is available at 

2 http://www.nrc.gov/reading-rm/sensitive-info.html. 

3 The regulations list various forms of information that can be protected from public disclosure. 

4 These include 

5  trade secrets and commercial or financial information 

6  interagency or intra-agency memoranda or letters that would not be available by law to a 

7 party other than an agency in litigation with NRC 

8  certain records or information compiled for law enforcement purposes 

9  geological and geophysical information and data, including maps, or information 

10 concerning wells 

11  personnel, medical, and other information, the disclosure of which would constitute a 

12 clearly unwarranted invasion of personal privacy 

13 In 10 CFR 2.390, NRC specifies the procedures and requirements for persons to submit 

14 sensitive information to NRC so that it may be properly protected from disclosure. This 

15 regulation is available electronically on the NRC Web site at http://www.nrc.gov/reading-rm/doc16 collections/cfr. 

17 Except for personal privacy information, which is not subject to the affidavit requirement, if NRC 

18 determines that the application or affidavit is deficient (i.e., does not contain the required 

19 information as outlined in 10 CFR 2.390), the applicant will be notified that additional information 

20 is needed and that the review will continue when the required information is received. 

21 If the request is denied, in whole or in part, NRC will give the applicant the option of withdrawing 

22 the information or application, as permitted in 10 CFR 2.390. If the applicant decides not to 

23 withdraw the information or application, NRC will notify the applicant, in writing, that the request 

24 for withholding has been denied and that NRC will disregard any references concerning the 

25 proprietary status of the information. 

26 Any part of a license application or information provided by a licensee or applicant that the NRC 

27 determines should be withheld from public disclosure will be handled in accordance with 

28 Management Directive 12.6, “NRC Sensitive Unclassified Information Security Program,” and 

29 the licensee or applicant will be notified, in writing, that NRC plans to honor the request. 

30 Management Directive 12.6 is available electronically on the NRC Web site at 

31 http://www.nrc.gov/reading-rm/doc-collections/management-directives/. 
6-3 

Anyone submitting a request to withhold information from public disclosure should thoroughly 

review 10 CFR 2.390 and be familiar with its requirements and limitations. 

Withholding from public inspection will not affect the right, if any, of persons properly and 

directly concerned to inspect the documents. If the need arises, NRC may send copies of this 

information to NRC consultants working in that area. NRC will ensure that the consultants 

have signed the appropriate agreements for handling proprietary information. 

If the basis for withholding this information from public inspection should change in the future, 

such that the information could then be made available for public inspection, the licensee or 

applicant should promptly notify the NRC. The licensee or applicant also should understand 

that NRC may have cause to review this determination in the future; for example, if the scope 

of a Freedom of Information Act request includes the information in question. In all review 

situations, if NRC makes a determination adverse to the above, the licensee or applicant will 

be notified in advance of any public disclosure. Anyone submitting commercial or financial 

information they believe to be privileged, confidential, or a trade secret must remember that 

the NRC’s policy is to achieve an effective balance between legitimate concerns for the 

protection of competitive positions and the right of the public to be fully apprised of the basis 

for, and the effects of, licensing or rulemaking actions. It is within NRC’s discretion to withhold 

such information from public disclosure. 

7-1 

1 7 APPLICATION AND LICENSE FEES 

2 Each application for which a fee is specified must be accompanied by the appropriate fee. 

3 Refer to Title 10 of the Code of Federal Regulations (10 CFR) 170.31, “Schedule of fees for 

4 materials licenses and other regulatory services, including inspections, and import and export 

5 licenses,” to determine the amount of the fee. The U.S. Nuclear Regulatory Commission (NRC) 

6 will not issue a license until the fee is received. Consult 10 CFR 170.11, “Exemptions,” for 

7 information on exemptions from these fees. Once the technical review of an application has 

8 begun, no fees will be refunded. Application fees will be charged regardless of the NRC’s 

9 disposition of an application or the withdrawal of an application. 

10 Most NRC licensees are also subject to annual fees; refer to 10 CFR 171.16, “Annual fees: 

11 Materials licensees, holders of certificates of compliance, holders of sealed source and device 

12 registrations, holders of quality assurance program approvals, and government agencies 

13 licensed by the NRC.” Consult 10 CFR 171.11 for information on exemptions from annual fees 

14 and 10 CFR 171.16(c) on reduced annual fees for licensees that qualify as “small entities.” 

15 Note that in order to pay reduced fees, a licensee that qualifies as a “small entity” must provide 

16 proper certification of this status to the NRC each year along with its annual fee payment. 

17 Direct all questions about the NRC’s fees or completion of Item 12 of NRC Form 313 to the 

18 Office of the Chief Financial Officer at NRC Headquarters in Rockville, Maryland, 301-415-7554. 

19 Information about fees may also be obtained by calling NRC’s toll-free number, 800-368-5642, 

20 extension 415-7554. The e-mail address is Fees.Resource@nrc.gov.

8-1 

1 8 CONTENTS OF AN APPLICATION 

2 The following information applies to the indicated items on U.S. Nuclear Regulatory Commission 

3 (NRC) Form 313 (Appendix A of this NUREG). 

4 All items in the application should be completed in enough detail for the NRC to determine 

5 whether the proposed equipment, facilities, training and experience, and radiation safety and 

6 security programs satisfy regulatory requirements and are adequate to protect public health and 

7 safety and minimize danger to life and property. Consideration should be given, when 

8 developing the application, to the concepts of keeping exposure as low as is reasonably 

9 achievable (ALARA), minimizing contamination, and maintaining control of radioactive materials. 

10 Title 10 of the Code of Federal Regulations (10 CFR) 20.1101(b) states: “The licensee shall 

11 use, to the extent practical, procedures and engineering controls based upon sound radiation 

12 protection principles to achieve occupational doses and doses to members of the public that are 

13 as low as is reasonably achievable (ALARA).” Regulatory Guide 8.10, Rev. 2, “Operating 

14 Philosophy for Maintaining Occupational Radiation Exposures as Low as Is Reasonably 

15 Achievable,” discusses the ALARA concept and philosophy. The application should 

16 document ALARA considerations, including establishing administrative action levels and 

17 monitoring programs. 

18 10 CFR 20.1406, “Minimization of contamination,” requires applicants for licenses to describe 

19 how facility design and procedures for operation will minimize, to the extent practicable, 

20 contamination of the facility and the environment; facilitate eventual decommissioning; and 

21 minimize, to the extent practicable, the generation of radioactive waste. As with ALARA 

22 considerations, applicants should address these concerns for all aspects of their programs. 

23 The application should include information on how the licensee will implement the security 

24 requirements in 10 CFR 20.1801, “Security of stored material,” and 10 CFR 20.1802, “Control of 

25 material not in storage.” All information submitted to the NRC during the licensing process may 

26 be incorporated as part of the license and will be subject to review during inspection. 

27 8.1 Item 1: License Action Type 

28 Item 1 of NRC Form 313 states the following: 

29 This is an application for (check appropriate item): 

Type of Action License No.

[ ] A. New License Not Applicable 

[ ] B. Amendment XX-XXXXX-XX 

[ ] C. Renewal XX-XXXXX-XX 

30 Check Box A for a new license request. Note that a prelicensing visit may be required prior to 

31 issuance of the license. Also note that an initial security inspection may be conducted in 

32 accordance with NRC Inspection Manual chapter 2800, “Materials Inspection Program,” before 

33 issuance of the license. 

34 Check Box B for an amendment to an existing license and provide the license number. 

35 Check Box C for a renewal of an existing license and provide the license number. 
8-2 

1 See “License Amendments And Renewals” in Chapter 9 of this NUREG. 

2 8.2 Item 2: Name and Mailing Address of Applicant 

3 List the legal name of the applicant’s corporation or other legal entity with direct control over use 

4 of the radioactive material. A division or department within a legal entity may not be a licensee. 

5 An individual may be designated as the applicant only if the individual is acting in a private 

6 capacity and the use of the radioactive material is not connected with employment in a 

7 corporation or other legal entity. Provide the mailing address where correspondence should be 

8 sent. A post office box number is an acceptable mailing address. 

9 Notify the NRC of changes in the mailing address. These changes do not require a fee. 

10 Note: The NRC must be notified and the transfer approved before control of the license is 

11 transferred (see Section 9.1, “Timely Notification of Transfer of Control”). The NRC must also 

12 be notified when bankruptcy proceedings have been initiated (see Section 8.2.1, “Notification of 

13 Bankruptcy Proceedings”). 

14 8.2.1 Notification of Bankruptcy Proceedings 

15 Regulation: 10 CFR 30.34(h) 

16 Criteria: Immediately following the filing of a voluntary or involuntary petition for bankruptcy for 

17 or against a licensee, the licensee must notify the appropriate NRC regional administrator, in 

18 writing, identifying the bankruptcy court in which the petition was filed and the date of filing. 

19 Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains 

20 subject to all applicable NRC regulatory requirements. The NRC must be notified when 

21 licensees are in bankruptcy proceedings in order to determine whether all licensed material is 

22 accounted for and adequately controlled and whether there are any public health and safety 

23 concerns (e.g., contaminated facility). The NRC shares the results of its determinations with 

24 other involved entities (e.g., trustee), so that health and safety issues can be resolved before 

25 bankruptcy actions are completed and the NRC may request that the United States Department 

26 of Justice (DOJ) represent the NRC’s interests in the bankruptcy proceeding. 

27 Response from Applicant: No response is required at the time of application for a new 

28 license. Licensees must immediately notify the NRC, in writing, following the filing of a voluntary 

29 or involuntary petition for bankruptcy by or against the licensee. 

30 Reference: See NUREG-1556, Volume 15, “Consolidated Guidance About Materials 

31 Licenses: Guidance About Changes of Control and About Bankruptcy Involving Byproduct, 

32 Source, or Special Nuclear Materials Licenses.” 

33 8.3 Item 3: Address(es) Where Licensed Material Will Be Used or 

34 Possessed 

35 Specify the street address, city, and State or other descriptive address (e.g., on Highway 10, 

36 5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State) for each 

37 facility. The descriptive address should be sufficient to allow an NRC inspector to find the 

38 facility location. A post office box address is not acceptable (see Figure 8-1). In addition, 

39 applicants are encouraged to provide global positioning system (GPS) coordinates, as 
8-3 

1 appropriate, for each permanent storage or use facility and field station located in a 

2 remote area. 

3 A license amendment is required before receiving, using, or storing licensed material at an 

4 address or location not already listed on the license. 

An NRC license does not relieve a licensee from complying with other applicable Federal, 

State, or local regulations (e.g., local zoning requirements). 

5 If an applicant submits documents that give the exact location of use and storage for any 

6 amount of radioactive material, the applicant should mark these documents as 

7 “Security-Related Information—Withhold under 10 CFR 2.390.” See Chapter 6, “Identifying and 

8 Protecting Sensitive Information,” for more details. 

9 Response from Applicant: 

10  Provide the specific address of each location of use. 

An acceptable location of use specifies street address, city, State, and zip code and does not include a post 

office box number.

Figure 8-1. Location of Use 

11 Note: As discussed in Section 8.5.2, “Financial Assurance and Recordkeeping for 

12 Decommissioning,” licensees must maintain permanent records that describe where licensed 

13 material was used or stored while the license was in effect. This is important for making future 

14 determinations about the release of these locations for unrestricted use (e.g., before the license 

15 is terminated). Acceptable records are sketches, written descriptions of the specific locations or 

16 room numbers where licensed material is used or stored and any records of leaking radioactive 

17 sources or other unusual occurrences involving the possible spread of contamination in or 

18 around the licensee’s facilities. 

RPh17a.ppt

082898

32 Elm St.

City, ST 12345 P.O. Box XXXX

City, ST 12345

32 ELM St.
8-4 

1 8.4 Item 4: Person to Be Contacted About This Application 

2 Identify the individual who can answer questions about the application, and include a telephone 

3 number where the individual may be contacted as well as business cell phone numbers and 

4 e-mail addresses. This individual, usually the radiation safety officer (RSO), will serve as the 

5 point of contact during the review of the application. If this individual is not a full-time employee 

6 of the licensed entity, his or her position and relationship to the licensee should be specified. 

7 The NRC should be notified if the person assigned to this function changes or if his or her 

8 telephone number, cell phone number, or e-mail address changes. Notification of a contact 

9 change is only provided for informational purposes and would not be considered an application 

10 for license amendment, unless the notification involves a change in the contact person who is 

11 also the RSO. 

As indicated on NRC Form 313 (Appendix A of this NUREG), Items 5 through 11 should be 

submitted on separate sheets of paper. Applicants may use Appendix B of this NUREG for 

this purpose and should note that using the suggested wording of responses and committing to 

using the model procedures in this NUREG will facilitate the NRC’s review. 

12 8.5 Item 5: Radioactive Material 

13 8.5.1 Sealed and/or Unsealed Byproduct Material 

14 Regulations: 10 CFR 30.4, 10 CFR 30.33, 10 CFR 32.72(a)(3), 10 CFR 30.32(g), 

15 10 CFR 32.210, 10 CFR 30.32(i), 10 CFR Part 37 

16 Criteria: Applicants must submit information specifying each radionuclide requested, the form, 

17 and the maximum activity to be possessed at any one time. For sealed sources, the applicant 

18 must also submit the manufacturer and model number of each requested sealed source. 

19 Licensees must also protect aggregated Category 1 and Category 2 quantities of radioactive 

20 material, as defined in 10 CFR 37.5, from theft, diversion, and sabotage. 

21 On August 8, 2005, the Energy Policy Act of 2005 (EPAct) gave the NRC the authority to 

22 regulate certain naturally occurring and accelerator-produced radioactive material (NARM) by 

23 expanding the definition of “byproduct material” as defined in the Atomic Energy Act (AEA). The 

24 expanded definition of byproduct material also includes certain discrete sources of radium-226. 

25 See 10 CFR 30.4, “Definitions,” for a complete definition of the term “byproduct material.” 

26 Applicants and licensees should determine whether they possess or will possess sealed 

27 sources or devices containing byproduct material as it is now defined in the AEA, which would 

28 include check, calibration, and reference sources that are not generally licensed or exempt from 

29 licensing. Applicants will have to request authorization for possession of these sealed source(s) 

30 or device(s). 

31 Note that NARM sealed sources and devices that were manufactured before 

32 November 30, 2007, may not have been registered by the NRC in accordance with 

33 10 CFR 32.210(c) or an Agreement State. If the applicant possesses unregistered 

34 sources and/or devices and is unable to provide all categories of information specified in 

35 10 CFR 32.210(c), the applicant must submit the information required by 10 CFR 30.32(g)(2),(3) 

36 or (4). 
8-5 

1 Discussion: Each authorized radionuclide is listed on an NRC license by its element 

2 name, form, and the maximum amount the licensee may possess at any one time 

3 (maximum possession limit). For each radium-226 sealed source and device and discrete 

4 source of radium-226 requested, provide the activity per source and the maximum possession 

5 limit [e.g., 1 millicurie (mCi) per source with a maximum possession limit of 3 mCi]. 

6 The applicant should list each requested radionuclide by its element name and its mass number 

7 (e.g., technetium-99m, indium-111, and fluorine-18) in Item 5. The NRC provides broad 

8 authorization to permit radiopharmacy licensees flexibility to prepare and distribute a range of 

9 radionuclides as new radioactive drugs are developed. It is necessary to specify whether the 

10 material will be acquired and used in unsealed or sealed form or in the case of radium-226, in 

11 the form of a discrete source. The name of the specific chemical compound that contains the 

12 radionuclide is not generally required. 

13 For unsealed radioactive material, it is also necessary to specify whether requested 

14 radionuclides will be handled in volatile or nonvolatile form, because additional safety 

15 precautions are required when handling and using material in a volatile form. For example, 

16 when requesting authorization to possess and distribute iodine-131, the applicant must specify 

17 whether the material will be manipulated at the radiopharmacy in a volatile form 

18 (e.g., compounding of iodine-131 capsules) or received in the form in which it will be distributed 

19 (e.g., redistribution of sealed, unopened vials of iodine-123). Also, if the pharmacy possesses 

20 discrete sources of radium-226, the discrete source should be described, because additional 

21 precautions may need to be taken if the source is compromised. Applicants requesting discrete 

22 sources of radium-226 and authorization to manipulate volatile radioactive material must 

23 describe appropriate facilities and engineering controls in response to Section 8.9, “Facilities 

24 and Equipment,” and radiation safety procedures for handling such material in specific 

25 responses to Section 8.10.4, “Occupational Dose;” Section 8.10.5, “Public Dose;” 

26 Section 8.10.6, “Safe Use of Radionuclides and Emergency Procedures;” and Section 8.10.7, 

27 “Surveys.” 

28 The anticipated possession limit in becquerels (Bq) or curies (Ci) for each radionuclide should 

29 also be specified. Possession limits must include the total anticipated inventory, including 

30 licensed material in storage and waste, and should be commensurate with the applicant’s needs 

31 and facilities for safe handling. Applicants should review the requirements for submitting a 

32 certification for financial assurance (FA) for decommissioning before specifying possession 

33 limits of any radionuclide with a half-life greater than 120 days. These requirements are 

34 discussed in Section 8.5.2, “Financial Assurance and Recordkeeping for Decommissioning.” 

35 Applicants that produce radionuclides using an accelerator [e.g., Positron Emission 

36 Tomography (PET) cyclotron] would list only those radionuclides produced for use in the 

37 pharmacy (e.g., fluorine-18). All other radionuclides associated with PET radionuclide 

38 production (e.g., activation products) should be provided with the application submitted in 

39 accordance with NUREG-1556, Volume 21, “Consolidated Guidance About Materials Licenses: 

40 Program-Specific Guidance About Possession Licenses for Production of Radioactive Material 

41 Using an Accelerator.” 

42 A safety evaluation of sealed sources and devices is performed by the NRC or an Agreement 

43 State before authorizing a manufacturer (or distributor) to distribute them to specific licensees. 

44 The safety evaluation is documented in a Sealed Source and Device (SSD) registration 

45 certificate. Applicants must provide the manufacturer’s name and model number for each 
8-6 

1 requested sealed source and device so that the NRC can verify that they have been evaluated 

2 in an SSD registration certificate or specifically approved on a license. 

3 A pharmacy possessing a sealed source containing byproduct material that does not have an 

4 SSD registration certificate must provide the information required under 10 CFR 30.32(g). As 

5 noted earlier, some sealed sources that contain accelerator-produced radioactive materials or 

6 radium-226 may not have existing safety evaluations. A pharmacy that intends to manufacture, 

7 distribute, or redistribute such a source must request a safety evaluation by the NRC or an 

8 Agreement State. 

9 Applicants should consult with the proposed supplier, manufacturer, or distributor to ensure that 

10 requested sources and devices are compatible with and conform to the sealed source and 

11 device designations registered with the NRC or an Agreement State. Licensees may not make 

12 any changes to the sealed source, device, or source/device combination that would alter the 

13 description or specifications from those indicated in the respective SSD registration certificates, 

14 without obtaining NRC’s prior permission in a license amendment. To ensure that applicants 

15 use sources and devices according to the certificates, they should obtain copies of the 

16 certificates and review them or discuss them with the manufacturer. 

To obtain copies of the SSD registration certificate, applicants should contact the manufacturer 

or distributor of the device or contact NMSS. For additional guidance relating to sealed 

sources and devices, see also NUREG-1556, Volume 3, “Applications for Sealed Source and 

Device Evaluation and Registration.” 

17 The applicant must also request authorization to possess depleted uranium (DU) if it will be 

18 used as shielding for molybdenum-99/technetium-99m generators or as other shielding. DU is 

19 frequently used as shielding for generators when the molybdenum-99 activity is greater than 

20 148 gigabecquerels (GBq) [4 Ci]. In 10 CFR 40.13(c)(6), DU is exempt from the requirements 

21 for a license, to the extent that the material is used as a shipping container, such as when 

22 molybdenum-99/technetium-99m generators are in transit from their manufacturer to the 

23 pharmacy; however, a specific license or authorization from NRC is needed to possess and use 

24 the DU as a shield during the time that the pharmacy uses or stores the generator at its facility. 

25 The applicant must specify the total amount of DU, in kilograms (kg), that will be needed. 

26 If an applicant requests quantities of licensed material in excess of those specified in 

27 10 CFR 30.72, “Schedule C—Quantities of radioactive materials requiring consideration of the 

28 need for an emergency plan for responding to a release,” the applicant must either submit an 

29 emergency plan for responding to a release of radioactive materials or perform an evaluation 

30 showing that the maximum dose to a person offsite due to a release of radioactive materials 

31 would not exceed 10 millisievert (mSv) [1 rem] effective dose equivalent or The 50 mSv [5 rem] 

32 to the thyroid. For radiopharmacies, iodine-131 is the radionuclide most likely to trigger the 

33 need for an emergency plan due to its Schedule C quantity of 10 Ci. 

34 Licensees must submit a license amendment and receive NRC authorization before they may 

35 make changes in the types, forms, and quantities of materials possessed. 

36 
8-7 

The regulations in 10 CFR Part 37 apply to licensees that possess an aggregated “Category 1 

quantity of radioactive material” or “Category 2 quantity of radioactive material.” These terms 

are defined in 10 CFR 37.5, and the radionuclides referenced in these 10 CFR 37.5 definitions 

are listed in Appendix A to 10 CFR Part 37. See Section 8.10.14, “Security Program for 

Category 1 and Category 2 Radioactive Material,” of this NUREG for more information on the 

applicability and requirements of 10 CFR Part 37. 

1 Response from Applicant: 

2  For unsealed materials 

3 — Identify each radionuclide (element name and mass number) that will be used, 

4 the form, and the maximum requested possession limit. 

5 AND 

6 — For potentially volatile materials (e.g., iodine-123, iodine-131), specify whether 

7 the materials will be manipulated at the radiopharmacy. 

8  For sealed sources and discrete sources of radium-226 

9 — Identify each radionuclide (element name and mass number) that will be used 

10 in each source, the activity per source, and the maximum requested 

11 possession limit. 

12 — Provide the manufacturer’s (distributor’s) name and model number for each 

13 sealed source and device and discrete source of radium-226 requested. 

14 — Confirm that each sealed source, device, source/device combination, and 

15 discrete source of radium-226 is registered as an approved sealed source, 

16 device, or discrete source by the NRC or an Agreement State. 

17 — Confirm that the activity per source and maximum activity in each device will not 

18 exceed the maximum activity listed on the approved certificate of registration 

19 issued by the NRC or by an Agreement State. 

20 — If the above information cannot be provided for the discrete source of 

21 radium-226, describe the discrete source and its physical boundaries. 

22  For DU, specify the total amount (in kilograms). 

23 8.5.2 Financial Assurance and Recordkeeping for Decommissioning 

24 Regulations: 10 CFR 30.35, 10 CFR 30.34(b), 10 CFR 30.51(f) 

25 Criteria: A licensee authorized to possess licensed material in excess of the limits specified in 

26 10 CFR 30.35, 10 CFR 40.36, and 10 CFR 70.25—all titled “Financial Assurance and 

27 Recordkeeping for Decommissioning”—must submit a decommissioning funding plan (DFP) or 

28 provide a certification of financial assurance for decommissioning (FA). 
8-8 

1 All licensees are required to maintain records of information important to the decommissioning 

2 of the facility in an identified location until the site, or any area, is released for unrestricted use. 

3 Before licensed activities are transferred or assigned in accordance with 10 CFR 30.34(b), 

4 10 CFR 40.46, and/or 10 CFR 70.36, licensees must transfer records important to 

5 decommissioning to the new proposed licensee in accordance with 10 CFR 30.35(g), 

6 10 CFR 40.36(f), and/or 10 CFR 70.51(b)(3), respectively. Furthermore, before a license is 

7 terminated, the licensee must send records important to decommissioning that are required by 

8 10 CFR 30.35(g), 10 CFR 40.36(f), and/or 10 CFR 70.25(g) to the appropriate NRC regional 

9 office in accordance with 10 CFR 30.51(f), 10 CFR 40.61(f), and/or 10 CFR 70.51(a)(3), 

10 respectively. 

11 Licensees are required to maintain, in an identified location, decommissioning records related to 

12 structures and equipment where devices are used or stored, as well as records related to 

13 leaking sources. Pursuant to 10 CFR 30.35(g), licensees must transfer records important to 

14 decommissioning to new licensees before licensed activities are transferred or assigned, 

15 according to 10 CFR 30.34(b). Furthermore, pursuant to 10 CFR 30.51(f), prior to license 

16 termination, each licensee must forward the records required by 10 CFR 30.35(g) to the 

17 appropriate NRC regional office. 

18 Discussion: The requirements for FA are specific to the types and quantities of byproduct 

19 material authorized on a license. Most commercial radiopharmacy applicants and licensees do 

20 not need to take any action to comply with the FA requirements, because the vast majority of 

21 radioactive materials they possess and redistribute do not have half-lives greater than 120 days 

22 and the total inventory of licensed materials with half-lives greater than 120 days does not 

23 exceed the thresholds in 10 CFR 30.35(b) and (d). 

24 Applicants requesting more than one radionuclide may determine whether FA for 

25 decommissioning is required by calculating, for each radionuclide with a half-life greater 

26 than 120 days possessed, the ratio between the activity possessed, in curies, and the 

27 radionuclide’s threshold activity requiring FA, in curies. If the sum of such ratios for all of the 

28 radionuclides possessed exceeds “1” (i.e., “unity”), applicants must submit evidence of FA 

29 for decommissioning. 

30 The regulations in 10 CFR 30.35(g) also require that licensees maintain records important to 

31 decommissioning in an identified location. All commercial nuclear pharmacy licensees need to 

32 maintain records of structures and equipment where radioactive material was used or stored. 

33 As-built drawings with modifications of structures and equipment shown as appropriate fulfill this 

34 requirement. If drawings are not available, licensees must substitute appropriate records 

35 (e.g., a sketch of the room or building or a narrative description of the area) concerning the 

36 specific areas and locations. If no records exist regarding structures and equipment where 

37 radioactive materials were used or stored, licensees shall make all reasonable efforts to create 

38 such records based upon historical information (e.g., employee recollections). In addition, if 

39 radiopharmacy licensees have experienced unusual occurrences (e.g., incidents that involve 

40 spread of contamination, leaking sources), they should also maintain records about 

41 contamination that remains after cleanup or contamination that may have spread to inaccessible 

42 areas. Leak test records are part of the decommissioning records. 

43 Before licensed activities are transferred or assigned in accordance with 10 CFR 30.34(b), 

44 10 CFR 40.46, and/or 10 CFR 70.36, licensees must transfer records important to 

45 decommissioning to the new licensee in accordance with 10 CFR 30.35(g), 10 CFR 40.36(f), 
8-9 

1 and/or 10 CFR 70.51(b)(3), respectively. Furthermore, before a license is terminated, 

2 the licensee must send records important to decommissioning that are required by 

3 10 CFR 30.35(g), 10 CFR 40.36(f), and/or 10 CFR 70.25(g) to the appropriate NRC regional 

4 office in accordance with 10 CFR 30.51(f), 10 CFR 40.61(f), and/or 10 CFR 70.51(a)(3), 

5 respectively. 

For radiopharmacy licensees whose contamination incidents did not involve radioactive 

materials with half-lives exceeding 120 days and whose sealed sources have never leaked, 

acceptable records important to decommissioning are sketches or written descriptions of the 

specific locations where radioactive material was used or stored. 

6 Response from Applicant: No response is needed from most applicants. If FA is required, 

7 submit the documentation required under 10 CFR 30.35. NUREG-1757, Volume 3, 

8 “Consolidated Decommissioning Guidance—Financial Assurance, Recordkeeping, and 

9 Timeliness,” dated February 2012, contains approved wording for each of the methods 

10 authorized by the regulation to guarantee or secure funds. 

11 Reference: NUREG-1757, Volume 3, “Consolidated Decommissioning Guidance—Financial 

12 Assurance, Recordkeeping, and Timeliness.” 

13 8.6 Item 6: Purposes For Which Licensed Material Will Be Used 

14 The distribution of radioactive materials by commercial radiopharmacies is authorized by 

15 several distinct regulations. The appropriate regulation to refer to depends on the nature of the 

16 material, the purpose(s) for which it will be used, and to whom it is sent. See narrative 

17 description below. 

Description of Radiopharmacy Activities and Applicable Requirements

Activities Authorized By 

Possession and Use of Byproduct Material 10 CFR 30.33 

Provide Leak Test, Instrument Calibration, or Other Services to 

Other Licensees 

License Condition 

Distribution of Radiochemicals and Radioactive Drugs to 

Veterinarians, Laboratories, and Other Radiopharmacies 10 CFR 30.41 Distribution of Radiochemicals to Medical Use Licensees Authorized 

Under 10 CFR Part 35 

Prepare and Distribute Radioactive Drugs to Medical Use Licensees 

Authorized Under 10 CFR Part 35 

10 CFR 32.72 

Redistribute Sealed Sources or Devices to Medical Use Licensees 

Authorized Under 10 CFR Part 35 

10 CFR 32.74 

Redistribute for In Vitro Clinical or Laboratory Testing to General 

Licensees: 10 CFR 31.11 

10 CFR 32.71 

 

Licensees must transfer records important to decommissioning either to the new licensee 

before licensed activities are transferred or assigned in accordance with 10 CFR 30.34(b) or to 

the appropriate NRC regional office before the license is terminated. 
8-10 

Description of Radiopharmacy Activities and Applicable Requirements

Activities Authorized By 

Manufacture and Distribution or Redistribution of Carbon-14 Urea 

Capsules Radioactive Drug for in vivo Human Diagnostic Use to 

Persons Exempt from Licensing: 10 CFR 30.21 

10 CFR 32.21 

Receive Pharmacy-Originated Radioactive Waste from Customers License Condition 

1 Applicants who are requesting authorization for the possession of sealed sources or devices 

2 containing sealed sources should note that an application for a license will be approved if the 

3 proposed activity is authorized by the Atomic Energy Act of 1954, as amended, and devices will 

4 be used only for the purposes for which they were designed and according to the 

5 manufacturer’s recommendations for use, as specified in an approved SSD 

6 registration certificate. 

7 8.6.1 Distribution and Redistribution of Sealed and Unsealed Materials 

8 Regulations: 10 CFR 30.41, 10 CFR 32.71, 10 CFR 32.72, and 10 CFR 32.74 

9 Criteria: The applicant must specify the radioactive material it intends to distribute 

10 and redistribute. 

11 Discussion: Radiochemicals are those materials that either require further manipulation to be 

12 suitable for human use or are not intended for human use. Examples include raw materials 

13 received from a non-10 CFR 32.72, supplier (chemical grade materials). Radioactive drugs are 

14 those materials suitable for human use and include radiobiologics (e.g., monoclonal antibodies 

15 and technetium-99m-tagged red blood cells) and radiopharmaceuticals. However, the terms, 

16 “radiopharmaceutical” and “radioactive drug” will be used interchangeably in this guidance 

17 document, and reference to one is not meant to exclude the other. 

18 Distribution activities are normally classified as either “distribution” or “redistribution.” 

19 “Distribution” applies to those radioactive drugs and radiochemicals initially prepared by the 

20 pharmacy. “Redistribution” refers to those materials received from another person, authorized 

21 pursuant to either 10 CFR 32.71, “Manufacture and distribution of byproduct material for certain 

22 in vitro clinical or laboratory testing under general license;”10 CFR 32.72, “Manufacture, 

23 preparation, or transfer for commercial distribution of radioactive drugs containing byproduct 

24 material for medical use under Part 35;” or 10 CFR 32.74, “Manufacture and distribution of 

25 sources or devices containing byproduct material for medical use,” depending on the 

26 product distributed (i.e., in vitro kits, other radiopharmaceuticals, or sealed sources for medical 

27 use, respectively). 

28 The distribution of radioactive materials to other persons requires specific approval from the 

29 NRC, either by NRC regulation or by a license authorizing the activity. The initial distribution of 

30 radioactive drugs for medical use must be prepared by a person licensed pursuant to 

31 10 CFR 32.72. The redistribution of in vitro kits and sealed sources containing byproduct 

32 material for medical use is authorized pursuant to 10 CFR 32.71 and 10 CFR 32.74, 

33 respectively, provided that the materials are not repackaged and the labels are not altered. The 

34 in vitro kits and sealed sources for medical use intended for redistribution must be initially 

35 distributed by a person licensed pursuant to 10 CFR 32.71 or 10 CFR 32.74, respectively. The 

36 transfer of radioactive materials for nonmedical use, including radiochemicals, and sealed 

37 calibration and reference sources, is authorized pursuant to 10 CFR 30.41, “Transfer of 

38 byproduct material.” 
8-11 

1 All radioactive material listed above shall be distributed only to persons authorized by an NRC 

2 or Agreement State license to receive such materials, or by a general license (10 CFR 31.11, or 

3 equivalent Agreement State regulation) to receive in vitro test materials. 

4 Initial distribution of unsealed byproduct material in the form of radiopharmaceuticals intended 

5 for human diagnostic and therapeutic use by medical licensees comprises the bulk of virtually all 

6 radiopharmacy activities. Before the transfer, distribution, or redistribution of any licensed 

7 material, the radiopharmacy must verify that the transferee’s license authorizes the receipt of 

8 the type, form, and quantity of byproduct material to be transferred. Five methods that can be 

9 used to meet the license verification requirement are listed in 10 CFR 30.41(d). The pharmacy 

10 shall verify that the address to which radioactive materials are delivered is an authorized 

11 location of use listed on the customer’s license. Radiopharmacies that plan to transfer, 

12 distribute, or redistribute licensed material to a mobile medical licensee’s mobile van or coach 

13 where there is no permanent structure for byproduct material storage should describe 

14 procedures to ensure that licensed material is securely and safely provided to the mobile 

15 medical licensee. 

16 Response From Applicant: 

17 For all transferred, distributed, and redistributed sealed and unsealed materials: 

18  Provide a statement that, “We have developed and will implement and maintain written 

19 procedures to meet the license verification requirements in accordance with 

20 10 CFR 30.41(d).” 

21 AND 

22  Describe procedures to ensure that sealed and unsealed materials are securely and 

23 safely provided to mobile medical licensees if they are transferred, distributed, or 

24 redistributed to a mobile medical licensee’s mobile van or coach where there is no 

25 permanent structure for byproduct material storage. For example, delivery directly to the 

26 van should only occur if the van is occupied by mobile medical licensee personnel at the 

27 time of delivery. 

28 AND 

29 Provide the following, as applicable: 

30 For radiopharmaceuticals: 

31  Confirm that radiopharmaceuticals will be prepared under the supervision of an 

32 authorized nuclear pharmacist (ANP) or will be obtained from a supplier authorized 

33 pursuant to 10 CFR 32.72, or under equivalent Agreement State requirements. 

34  Describe all licensed material to be distributed or redistributed. 

35 For generators: 

36  Confirm that the generators will be obtained from a manufacturer licensed pursuant to 

37 10 CFR 32.72, or under equivalent Agreement State requirements. 
8-12 

 Confirm that unused generators will be redistributed without opening or altering the 

manufacturer’s packaging. 

1 For redistribution of used generators: 

2  Describe the procedures and instructions for safely repackaging the generators, 

3 including the use of the manufacturer’s original packaging and minimization of migration 

4 of radioactive fluids out of the generator during transport. 

5  Confirm that the manufacturer’s packaging and labeling will not be altered. 

6  Confirm that the generator will not be distributed beyond the expiration date shown on 

7 the generator label. 

8  Confirm that the redistributed generator will be accompanied by the 

9 manufacturer-supplied leaflet or brochure that provides radiation safety instructions for 

10 handling and using the generator. 

11  Confirm that only generators used in accordance with the manufacturer’s instructions will 

12 be redistributed. 

13 Note: Although redistribution of used generators may be authorized by the NRC, NRC approval 

14 does not relieve the licensee from complying with applicable U.S. Food and Drug Administration 

15 (FDA) or other Federal and State requirements. 

16 For redistribution of sealed sources for brachytherapy or diagnosis: 

17  Confirm that the sealed sources for brachytherapy or diagnosis to be redistributed will be 

18 obtained from a manufacturer authorized to distribute sealed sources for brachytherapy 

19 or diagnosis in accordance with a specific license issued pursuant to 10 CFR 32.74, or 

20 under equivalent Agreement State requirements. 

21  Confirm that the manufacturer’s packaging, labeling, and shielding will not be altered 

22 and that redistributed sources will be accompanied by the manufacturer-supplied 

23 package insert, leaflet, brochure, or other document that provides radiation safety 

24 instructions for handling and storing the sources. 

25 For redistribution of calibration and reference sealed sources: 

26  Confirm that calibration and reference sealed sources to be redistributed to medical use 

27 licensees will be obtained from a person licensed pursuant to 10 CFR 32.74 or under 

28 equivalent Agreement State requirements, to initially distribute such sources. 

29  Confirm that the manufacturer’s labeling and packaging will not be altered and that 

30 redistributed sources will be accompanied by the manufacturer-supplied calibration 

31 certificate and the leaflet, brochure, or other document that provides radiation safety 

32 instructions for handling and storing the sources. 
8-13 

1 For redistribution of prepackaged units for in vitro tests: 

2  Confirm that the prepackaged units for in vitro tests to be redistributed will be obtained 

3 from a manufacturer authorized to distribute the prepackaged units for in vitro tests in 

4 accordance with a specific license issued pursuant to 10 CFR 32.71, or under an 

5 equivalent license of an Agreement State. 

6 For redistribution of prepackaged units for in vitro tests to general licensees: 

7  Confirm that the manufacturer’s packaging and labeling of the prepackaged units for 

8 in vitro tests will not be altered in any way. 

9  Confirm that each redistributed prepackaged unit for in vitro tests will be accompanied 

10 by the manufacturer-supplied package insert, leaflet, or brochure that provides radiation 

11 safety instructions for general licensees. 

12 For redistribution of prepackaged units for in vitro tests to specific licensees: 

13  Confirm that the labels, package insert, leaflet, brochure, or other documents 

14 accompanying the redistributed prepackaged units for in vitro tests will NOT reference 

15 general licenses, exempt quantities, or NRC’s regulations that authorize a general 

16 license (e.g., 10 CFR 31.11). 

17  Confirm that the labeling on redistributed prepackaged units for in vitro tests will 

18 conform to the requirements of 10 CFR 20.1901, “Caution signs,” and 20.1904, 

19 “Labeling containers.” 

20 For redistribution of discrete sources of radium-226: 

21  Confirm that the discrete sources of radium-226 will be obtained by a manufacturer 

22 authorized to distribute it. 

23  Confirm that the manufacturer’s packaging, labeling, and shielding will not be altered 

24 and that redistributed sources will be accompanied by the manufacturer-supplied 

25 package insert, leaflet, brochure, or other document that provides radiation safety 

26 instructions for handling and storing sources. 

27  If the above cannot be confirmed, contact the appropriate NRC regional office for 

28 assistance. 

29 8.6.2 Preparation of Radiopharmaceuticals 

30 Regulation: 10 CFR 32.72(b) 

31 Criteria: The preparation of radiopharmaceuticals for commercial distribution to medical users 

32 requires specific authorization. 

33 Discussion: The bulk of radiopharmacy activities involve the preparation of 

34 radiopharmaceuticals for commercial distribution to medical users. 
8-14 

1 Response from Applicant: The applicant should indicate the types of radiopharmaceutical 

2 preparation activities it intends to perform (e.g., compounding of iodine-131 capsules, 

3 radioiodination, chemical synthesis of PET radiopharmaceuticals, and technetium-99m 

4 kit preparation). 

5 8.6.3 Sealed Sources for Calibration and Checks and Possession of Discrete 

6 Sources of Radium-226 and Depleted Uranium 

7 Regulations: 10 CFR 30.33, 10 CFR 30.32(g), 10 CFR 32.210 

8 Criteria: The applicant must specify the uses for discrete sources of radium-226, sealed 

9 sources for reference and calibration, and DU for shielding. 

10 Discussion: The applicant should describe the intended use of discrete sources of radium-226 

11 and sealed sources. This will normally be for calibration and checks performed only on the 

12 applicant’s instruments and equipment. Any sources intended for use in a specific instrument 

13 calibration device should be identified, along with the manufacturer and model number of the 

14 device. The use of DU for shielding (e.g., incorporated into molybdenum-99/technetium-99m 

15 generators) should also be specified, if appropriate. 

16 Response from Applicant: Supply specific information concerning the use of discrete sources 

17 of radium-226, sealed sources for reference and calibration, and DU for shielding. 

18 8.6.4 Service Activities 

19 Regulation: 10 CFR 30.33(a)(1) 

20 Criteria: The applicant must specify the radiation protection services it intends to provide to 

21 other licensees (e.g., customers), if the service involves the applicant’s possession of licensed 

22 material (e.g., calibration sources and leak test samples). 

23 Discussion: If the applicant intends to provide radiation protection services to customers, the 

24 services must be described. Typically these services include instrument calibration and sealed 

25 source leak testing. Specific guidance regarding requests to provide service activities is 

26 included in NUREG-1556, Volume 18, “Program-Specific Guidance About Service 

27 Provider Licenses.” 

28 Response from Applicant: Specify the customer radiation protection services involving 

29 licensed material that will be provided. Examples of customer radiation protection services that 

30 may be provided include: 

31  leak testing 

32  instrument calibration 

33  other, specify 
8-15 

1 8.7 Item 7: Individual(s) Responsible for Radiation Safety Program and 

2 Their Training and Experience 

3 Regulations: 10 CFR 30.33(a)(3), 10 CFR 32.72(b), and 10 CFR 35.55(b) 

4 Criteria: The RSO, Authorized Users (AUs), and Authorized Nuclear Pharmacists (ANPs) must 

5 have adequate training and experience. 

6 Discussion: Individuals responsible for the Radiation Protection Program are licensee senior 

7 management, the RSO, ANPs, and AUs. The NRC requires that an applicant be qualified by 

8 training and experience to use licensed materials for the purposes requested in such a manner 

9 as to protect health and minimize danger to life or property. Specific criteria are given in 

10 10 CFR 35.55(b) and 10 CFR 32.72(b) for acceptable training and experience for ANPs. The 

11 minimum training and experience criteria for RSOs and AUs, although not specifically described 

12 in the NRC’s regulations for radiopharmacy licensees, should include a Bachelor’s degree in a 

13 physical science, or equivalent, and previous experience handling and supervising similar 

14 activities. Applicants should note that a résumé or curriculum vitae does not usually supply all 

15 the information needed to evaluate an individual’s training and experience. 

16 The NRC holds the licensee responsible for the Radiation Protection Program; therefore, it is 

17 essential that strong management controls and oversight exist to ensure that licensed activities 

18 are conducted properly. Senior management should delegate to the RSO, in writing, sufficient 

19 authority, organizational freedom, and management prerogative to communicate with and direct 

20 personnel regarding NRC regulations and license provisions and to terminate unsafe activities 

21 involving byproduct material. The licensee maintains the ultimate responsibility, nevertheless, 

22 for the conduct of licensed activities. 

23 Response from Applicant: Applicants should submit an organizational chart describing the 

24 management structure, reporting paths, and the flow of authority between executive 

25 management and the RSO. Refer to the subsequent sections specific to the individuals 

26 described above. 

27 8.7.1 Radiation Safety Officer 

28 Regulations: 10 CFR 30.33(a)(3) 

29 Criteria: Each licensee must appoint a qualified individual to act as the RSO. The RSO must 

30 have adequate training and experience. 

31 Discussion: The person responsible for the radiation protection program is the RSO. The 

32 RSO is the key to overseeing and ensuring safe and secure operation of the licensee’s radiation 

33 protection program. The RSO must have adequate training to understand the hazards 

34 associated with radioactive material and be familiar with all applicable regulatory requirements. 

35 The RSO should have independent authority to stop operations that he or she considers to be 

36 unsafe. He or she should have sufficient time, support, and commitment from management to 

37 fulfill his or her duties and responsibilities to ensure that radioactive materials are used in a safe 

38 manner, approved radiation safety procedures are being implemented, and the required records 

39 of licensed activities are maintained. Typical duties and responsibilities of a radiopharmacy 

40 RSO are included in Appendix E of this NUREG. The NRC requires the name of the RSO to be 

41 listed on the license to ensure that the licensee management always has a responsible, 
8-16 

1 qualified person identified and that the named individual knows of his or her designation 

2 as RSO. 

3 The RSO needs a level of basic technical knowledge sufficient to understand the work to be 

4 performed with byproduct materials at the radiopharmacy and to be qualified by training and 

5 experience to perform the duties required for that position. Any individual who has sufficient 

6 training and experience to be named as an ANP is also considered qualified to serve as the 

7 facility RSO. The same is true for an AU who has had adequate training and experience in the 

8 radiation safety aspects associated with the use of similar types of byproduct material. 

9 The training and experience requirements for the RSO may be met by any of the following: 

10  qualification as an ANP 

11  identification as an AU on the license and experience in the use of the types and 

12 quantities of licensed material for which the individual has RSO responsibilities 

13  didactic and work experience 

14 In order to demonstrate adequate training and experience, the RSO should have (i) at a 

15 minimum, a college degree at the Bachelor level or equivalent training and experience in 

16 physical, chemical, biological sciences, or engineering; and (ii) training and experience 

17 commensurate with the scope of proposed activities. Training should include the 

18 following subjects: 

19  radiation protection principles 

20  characteristics of ionizing radiation 

21  units of radiation dose and quantities 

22  radiation detection and measurement instrumentation 

23  biological hazards of exposure to radiation (appropriate to types and forms of byproduct 

24 material to be used) 

25  NRC regulatory requirements and standards 

26  hands-on use of radioactive materials commensurate with the uses proposed by 

27 the applicant 

28 The length of training and experience will depend upon the type, form, quantity, and proposed 

29 use of the licensed material requested. The proposed RSO’s training and experience should be 

30 sufficient to identify and control the anticipated radiation hazards. The requisite training may be 

31 obtained from formal courses consisting of lectures and laboratories designed for RSOs 

32 presented by academic institutions, commercial radiation safety consulting companies, or 

33 appropriate professional organizations. Each hour of training may be counted only once and 

34 should be allocated to the most representative topic. 
8-17 

1 On-the-job training may not be counted toward the hours documenting length of training unless 

2 it was obtained as part of a formal training course. A “formal” training course is one that 

3 incorporates the following elements: 

4  A detailed description of the content of the course is maintained on file at the sponsoring 

5 institution and can be made available to the NRC upon request. 

6  A detailed description of how the sponsoring institution examined the student’s 

7 knowledge of the course content (e.g., include a final grade or percentile) which is 

8 maintained on file at the institution and can be made available to NRC upon request; and 

9  A permanent record that the student successfully completed the course is kept at 

10 the institution. 

11 The qualifications described above only apply to an RSO for a radiopharmacy that prepares 

12 radioactive drugs or redistributes other products. NUREG-1556, Volume 21, “Consolidated 

13 Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses 

14 for Production of Radioactive Material Using an Accelerator” provides training and experience 

15 guidance for individuals that will be RSOs at radionuclide production facilities. 

16 Response from Applicant: Provide the following: 

17  name of the proposed RSO 

18 AND 

19  a copy of the license (NRC or Agreement State) that authorized the uses requested and 

20 on which the individual was specifically named as the RSO, ANP, or AU 

21 OR 

22  description of the training and experience demonstrating that the proposed RSO is 

23 qualified by training and experience applicable to commercial nuclear pharmacies 

24 Note: See Table D–1 in Appendix D of this NUREG for convenient formats to use for 

25 documenting hours of training in basic radionuclide handling techniques and hours of a 

26 experience using radionuclides. 

27 Note: Notify the NRC and obtain a license amendment before making changes in the 

28 designation of the RSO listed on the license. 

29 8.7.2 Authorized Nuclear Pharmacist (ANP) 

30 Regulations: 10 CFR 32.72 (b)(2), (4), and (5); 10 CFR 35.2; 10 CFR 35.55(a) and (b); and 

31 10 CFR 35.59 

32 Criteria: The ANP must be a State-licensed or State-registered pharmacist with adequate 

33 training and experience. 
8-18 

1 Discussion: Each commercial nuclear pharmacy must have an ANP to prepare or supervise 

2 the preparation of radioactive drugs for medical use. An individual who is not qualified to be an 

3 ANP may work under the supervision of an ANP. 

4 The criteria for a pharmacist to work as an ANP at a commercial radiopharmacy are described 

5 in 10 CFR 32.72(b)(2) and (4). This section of the regulation refers to the training for an ANP, 

6 which includes the definition of an ANP in 10 CFR 35.2, “Definitions,” [which in turn includes the 

7 board certification requirements in 10 CFR 35.55(a)]; the training and experience criteria for the 

8 alternate pathway described in 10 CFR 35.55(b); and the recentness of training criteria in 

9 10 CFR 35.59, “Recentness of training,” that requires the successful completion of training 

10 within 7 years preceding the date of the application. Additional training and experience may be 

11 necessary if the time interval is greater than 7 years. Applicants may find it convenient to 

12 present this documentation using NRC Form 313A (ANP) in Appendix D of this NUREG. Each 

13 hour of training may be listed only once (i.e., under the most applicable category). The 

14 recentness of training requirements apply to board certification as well as to other recognized 

15 training pathways. 

16 In implementing the EPAct, the NRC “grandfathered” nuclear pharmacists by permitting the 

17 licensee to designate a pharmacist as an ANP if the pharmacist used only accelerator18 produced radioactive materials, discrete sources of Ra-226, or both, in the practice of nuclear 

19 pharmacy for the uses performed before November 30, 2007, or under the NRC waiver of 

20 August 31, 2005. These individuals do not have to meet the requirements of 

21 10 CFR 32.72(b)(2)(i) or (ii). However, the applicant must document that the individual 

22 meets the criteria in 10 CFR 32.72(b)(4). 

23 On-the-job training may not be counted toward the hours listed above unless it was obtained as 

24 part of a formal training course. A “formal” training course is one that incorporates the 

25 following elements: 

26  A detailed description of the content of the course is maintained on file at the sponsoring 

27 institution and can be made available to the NRC upon request; 

28  A detailed description of how the sponsoring institution examined the student’s 

29 knowledge of the course content (e.g., include a final grade or percentile) which is 

30 maintained on file at the institution and can be made available to NRC upon request; and 

31  A permanent record that the student successfully completed the course is kept at 

32 the institution. 

33 Response from Applicant: For each proposed ANP, provide the following: 

34  name of the proposed ANP 

35 AND 

36  pharmacist’s license number and issuing entity 

37 AND 
8-19 

1 For an individual previously identified as an ANP on an NRC or Agreement State license or 

2 permit or by a commercial nuclear pharmacy that has been authorized to identify ANPs 

3 [10 CFR 32.72(b)(2)(i)]: 

4  previous license number (if issued by the NRC) or a copy of the license (if issued by an 

5 Agreement State) or a copy of a permit issued by an NRC master materials licensee, a 

6 permit issued by an NRC or Agreement State broad scope licensee, or a permit issued 

7 by an NRC Master Material License broad scope permittee on which the individual was 

8 named an ANP or a copy of an authorization as an ANP from a commercial nuclear 

9 pharmacy that has been authorized to identify ANPs 

10 OR 

11 For an individual qualifying under 10 CFR 32.72(b)(4): 

 documentation that the individual was a nuclear pharmacist preparing only radioactive 

drugs containing accelerator-produced radioactive material 

12 AND 

13  documentation that the individual practiced at a pharmacy, a Government agency or 

14 federally recognized Indian Tribe before November 30, 2007, or at all other pharmacies 

15 before August 8, 2009, or an earlier date as noticed by the NRC 

16 OR 

17 For an individual qualifying under 10 CFR 35.55(a): 

18  copy of the certification(s) of the specialty board whose certification process has been 

recognized1 19 under 10 CFR 35.55(a) 

20 AND 

21  written attestation, signed by a preceptor ANP, that training and experience required for 

22 certification have been satisfactorily completed and that a level of competency sufficient 

23 to function independently as an ANP has been achieved 

24 AND 

25  if applicable, description of recent related continuing education and experience as 

26 required by 10 CFR 35.59 

27 OR 

 

1

The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the 

NRC’s Web page at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html. 
8-20 

1 For an individual qualifying under 10 CFR 32.72(b)(2)(ii): 

2  description of the training and experience specified in 10 CFR 35.55(b) demonstrating 

3 that the proposed ANP is qualified by training and experience 

4 AND 

5  written attestation, signed by a preceptor ANP, that training and experience required for 

6 certification have been satisfactorily completed and that a level of competency sufficient 

7 to function independently as an ANP has been achieved 

8 AND 

9  if applicable, description of recent related continuing education and experience as 

10 required by 10 CFR 35.59 

11 Notes:

12  NRC Form 313A (ANP), “Authorized Nuclear Pharmacist Training and Experience and 

13 Preceptor Attestation [10 CFR 35.55],” may be used to document training and 

14 experience for those individuals qualifying under 10 CFR 35.55(a) or (b). 

15  Descriptions of training and experience will be reviewed using the criteria listed above. 

16 The NRC will review the documentation to determine if the applicable criteria in 

17 10 CFR 32.72(b)(2) are met. If the training and experience do not appear to meet the 

18 criteria in Subpart B, the NRC may request additional information from the applicant or 

19 may request the assistance of the Advisory Committee on the Medical Uses of Isotopes 

20 (ACMUI) in evaluating such training and experience. 

21 8.7.3 Authorized Users (AU) 

22 Regulation: 10 CFR 30.33(a)(3). 

23 Criteria: AUs must have adequate training and experience with the types and quantities of 

24 licensed material that they propose to use. 

25 Discussion: If the applicant intends to perform functions other than the preparation and 

26 distribution of radioactive drugs, the applicant may request that an individual other than an ANP 

27 perform and/or supervise those functions. This individual, if approved, would be designated on 

28 the license as an AU. These other functions may include leak testing of sealed sources or 

29 instrument calibration services for the pharmacy and its customers; however, the term 

30 Authorized User, as used in this document, should not be confused with the definition of an 

31 “Authorized User” contained in 10 CFR 35.2 for medical use. 

32 In order to demonstrate adequate training and experience, the proposed AU should have: (1) at 

33 a minimum, a college degree at the bachelor level, or equivalent training and experience in 

34 physical, chemical, biological sciences, or engineering; and (2) training and experience 

35 commensurate with the scope of proposed activities. Training should include the 

36 following subjects: 
8-21 

1  radiation protection principles; 

2  characteristics of ionizing radiation; 

3  units of radiation dose and quantities; 

4  radiation detection and measurement instrumentation; 

5  biological hazards of exposure to radiation (appropriate to types and forms of byproduct 

6 material to be used); 

7  NRC regulatory requirements and standards; and 

8  hands-on use of radioactive materials commensurate with uses proposed by 

9 the applicant 

10 The length of training and experience listed above will depend upon the type, form, quantity, 

11 and proposed use of the licensed material requested. The proposed AU’s training and 

12 experience should be sufficient to identify and control the anticipated radiation hazards. The 

13 above training may be obtained from formal radiation safety courses consisting of lectures and 

14 laboratories presented by academic institutions, commercial radiation safety consulting 

15 companies, or appropriate professional organizations. Each hour of training may be counted 

16 only once and should be allocated to the most representative topic. 

17 On-the-job training may not count toward the hours listed above, unless it was obtained as 

18 part of a formal training course. A “formal” training course is one that incorporates the 

19 following elements: 

20  A detailed description of the content of the course is maintained on file at the sponsoring 

21 institution and can be made available to the NRC upon request. 

22  Evidence that the sponsoring institution has examined the student’s knowledge of the 

23 course content is maintained on file at the institution and can be made available to the 

24 NRC upon request. The evidence of the student’s overall competency in the course 

25 material should include a final grade or percentile. 

26  A permanent record that the student successfully completed the course is kept at 

27 the institution. 

28  The AU must demonstrate training and experience with the type and quantity of material 

29 that is to be used at the pharmacy. For example, someone with training and experience 

30 limited to gamma-emitters may not be qualified to use or supervise the use of 

31 high-energy beta emitters. 

32 Note that for applicants that produce radioactive material using an accelerator, the individual 

33 who handles byproduct materials during the maintenance and repair of an accelerator or other 

34 related equipment should also be considered an AU. However, training and experience 

35 documentation for these individuals should be submitted with the license application for 

36 radionuclide production as specified in NUREG-1556, Volume 21, “Consolidated Guidance 

37 About Materials Licenses: Program-Specific Guidance About Possession Licenses for 

38 Production of Radioactive Material Using an Accelerator.” 
8-22 

1 Response from Applicant: For each proposed AU, provide the following: 

2  name of each proposed AU 

3 AND 

4  types, quantities, and proposed uses of licensed material 

5 AND 

6  a copy of the license (NRC or Agreement State) on which the individual was specifically 

7 named as an AU for the types, quantities, and proposed uses of licensed materials 

8 OR 

9  a copy of the permit maintained by a licensee of broad scope that identifies the individual 

10 as an AU for the types, quantities, and proposed uses of licensed materials 

11 OR 

12  a description of the training and experience demonstrating that the proposed AU is 

13 qualified by training and experience to use the requested licensed materials. 

14 Note: The applicant may find it convenient to describe this training and experience using a 

15 format similar to Table D–1 in Appendix D of this NUREG. 

16 8.8 Item 8: Training for Individuals Working In or Frequenting Restricted 

17 Areas 

18 8.8.1 Occupationally Exposed Workers And Ancillary Personnel 

19 Regulations: 10 CFR 19.12, 10 CFR 20.1101(a), 10 CFR 30.33(a)(3), 10 CFR 37.43 

20 Criteria: Individuals working with licensed material must receive radiation safety training 

21 commensurate with their assigned duties and specific to the licensee’s Radiation Safety 

22 Program. In addition, those individuals who, in the course of employment, are likely to receive 

23 in a year an occupational dose in excess of 100 millirem (mrem) [1 mSv] must be instructed 

24 according to 10 CFR 19.12, “Instruction to workers.” Any licensee that possesses an 

25 aggregated Category 1 or Category 2 quantity of radioactive material (as defined in 

26 10 CFR 37.5) must implement a training program for those individuals implementing the 

27 security program. 

28 Discussion: Under 10 CFR 20.1101(a), each licensee is required to develop, document, and 

29 implement a Radiation Protection Program commensurate with the scope and extent of licensed 

30 activities and sufficient to ensure compliance with 10 CFR Part 20. Each individual working with 

31 radioactive material must be trained in the radiation safety procedures applicable to his/her job 

32 before beginning work with licensed materials. Licensees should not assume that safety 

33 instruction has been adequately covered by prior employment or training. Practical, site-specific 

34 training should be provided for all individuals before beginning work with, or in the vicinity of, 

35 licensed material. Training should also be performed whenever there is a significant change in 
8-23 

1 duties, procedures, regulations, or terms of the license. Each individual should also receive 

2 periodic refresher training at least annually to ensure that all staff remain adequately trained. 

3 Additional training is required if an individual is likely to receive a dose in excess of 1 mSv 

4 [100 mrem] in a year. ANPs and others involved in the preparation of radiopharmaceuticals are 

5 most likely to receive doses in excess of 1 mSv [100 mrem] in a year; however, potential 

6 radiation doses received by all employees must also be evaluated. The evaluation must include 

7 consideration of assigned activities during both normal and abnormal situations involving 

8 exposure to radiation and/or radioactive material that can reasonably be expected to occur 

9 during licensed activities. 

10 If individuals making deliveries of radioactive material at the licensee’s facility are likely to 

11 receive a dose in excess of 1 mSv [100 mrem] in a year from the licensee’s activities, the 

12 licensee is responsible for ensuring that the person has received the training specified in 

13 10 CFR Part 19 regardless of whether that person is an employee of the licensee. If the training 

14 has been provided by someone else (such as the shipper or another licensee), the licensee 

15 does not have to provide training except for instruction in site-specific radiation hazards. This 

16 issue is discussed in NRC Generic Letter (GL) 95-09, “Monitoring and Training of Shippers and 

17 Carriers of Radioactive Materials,” dated November 3, 1995. 

18 Training may be in the form of lectures, demonstrations, video presentations, and/or self-study, 

19 and should emphasize practical subjects important to the safe use of licensed material. A 

20 method for asking questions should be provided for individuals receiving instructions and 

21 training. The licensee should determine whether the training succeeded in conveying the 

22 desired information and adjust the training program as necessary. The person conducting the 

23 training should be a qualified individual (e.g., RSO, ANP, AU, or radiation safety professional 

24 familiar with the licensee’s program). 

25 Licensee personnel who work in the vicinity of, but do not handle radioactive materials 

26 (ancillary staff), are not required to have radiation safety training as long as they are not likely to 

27 receive 1 mSv [100 mrem] in a year; however, to minimize potential radiation exposure when 

28 ancillary staff are working in the vicinity of radioactive material, it is prudent for them to work 

29 under the supervision and in the physical presence of an ANP/AU or to be provided some basic 

30 radiation safety training. Such ancillary staff should be informed of the nature and location of 

31 the radioactive material and the meaning of the radiation symbol, and should be instructed not 

32 to handle radioactive material and to keep away from it as much as their work permits. 

33 Some ancillary staff, although not likely to receive doses over 1 mSv [100 mrem], should receive 

34 training to ensure adequate security and control of licensed material. Licensees may provide 

35 these individuals with training commensurate with their assignments in the vicinity of the 

36 radioactive material to ensure the control and security of the material. 

37 The guidance in Appendix K of this NUREG, “Model Personnel Training Program,” may be used 

38 by the applicant to develop a training program. 
8-24 

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

Category 2 quantity of radioactive material must implement a training program in accordance 

with 10 CFR 37.43, “General security program requirements,” and specifically, must comply 

with 10 CFR 37.43(c), “Training,” to ensure that those individuals who may have a 

responsibility to implement portions of the security program possess and maintain the 

knowledge, skills, and abilities to carry out their assigned duties and responsibilities effectively. 

Additionally, in accordance with 10 CFR 37.43(c)(3), refresher training must be provided at a 

frequency not to exceed 12 months and when significant changes have been made to the 

security program. For additional guidance on implementing 10 CFR Part 37 requirements, see 

NUREG-2155, “Implementation Guidance for 10 CFR Part 37, “Physical Protection of 

Category 1 and Category 2 Quantities of Radioactive Material.”” Additional information 

regarding best practices for protection of risk-significant radioactive material is available in 

NUREG–2166, “Physical Security Best Practices for the Protection of Risk-Significant 

Radioactive Material.” 

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection. 

1 Response from Applicant: State: “We have developed and will implement and maintain 

2 written procedures for a training program for each group of workers, including (i) topics covered, 

3 (ii) qualifications of the instructors, (iii) method of training, (iv) method for assessing the success 

4 of the training, (v) initial training, and (vi) annual refresher training.” 

5 Reference: NRC GL 95-09, “Monitoring and Training of Shippers and Carriers of Radioactive 

6 Materials,” dated November 3, 1995. 

7 8.8.2 Personnel Involved in Hazardous Materials Package Preparation and 

8 Transport 

9 Regulation: 49 CFR 172.700, 49 CFR 172.702, 49 CFR 172.704 

10 Criteria: Applicants must train personnel involved in the preparation and transport of hazardous 

11 material packages in the applicable DOT regulations. 

12 Discussion: Licensees who prepare packages of radioactive materials or who transport their 

13 own packages must provide training to their employees who perform those functions. The 

14 training must include 

15  general awareness and familiarization training designed to provide familiarity with 

16 DOT requirements to ensure that the employees recognize and identify 

17 hazardous materials 

18  function-specific training concerning the DOT requirements that are specifically 

19 applicable to the functions the employee performs (e.g., if the employee’s duties require 

20 affixing DOT radioactive labels to packages, the employee must receive training in 

21 DOT’s regulations governing package labeling) 

22  safety training concerning emergency response information; measures to protect the 

23 employee and other employees from the hazards associated with the hazardous 

24 materials to which they may be exposed in the workplace; and methods and procedures 
8-25 

1 for avoiding accidents, such as the proper procedures for handling packages containing 

2 hazardous materials 

3  security awareness training: training regarding awareness of security risks associated 

4 with hazardous materials transportation and methods designed to enhance 

5 transportation security 

6 The training must be provided initially and at least once every 3 years thereafter. Records of 

7 training must be maintained. 

8 Note: The licensee is not responsible for providing DOT-required hazardous materials training 

9 to common carriers to which the pharmacy offers radioactive materials packages for transport. 

10 Response from Applicant: Submit the following statement: “We have developed and will 

11 implement and maintain records and written procedures for training personnel involved in 

12 hazardous materials package preparation and transport that meet the requirements in 

13 49 CFR 172.700, 49 CFR 172.702, and 49 CFR 172.704, as applicable.” 

14 8.8.3 Instruction for Supervised Individuals Preparing Radiopharmaceuticals 

15 Regulations: 10 CFR 32.72(b)(1), 10 CFR 35.27(b) 

16 Criteria: Individuals who prepare byproduct material for medical use under the supervision of 

17 an ANP must be instructed in the preparation of byproduct material for medical use, the 

18 principles of radiation safety, and the licensee’s procedures for the use of byproduct material; 

19 must follow the instructions given; and must have their work, and records kept to reflect their 

20 work, periodically reviewed by the supervising ANP. 

21 Discussion: The applicant must instruct supervised individuals in the preparation of byproduct 

22 material for medical use and require those individuals to follow their instructions, the written 

23 Radiation Protection Program, license conditions, and NRC regulations. The supervising ANP 

24 must review the work of supervised individuals in the preparation of byproduct material for 

25 medical use and the records kept to reflect that work. If an ANP is always physically present 

26 when radioactive drugs are prepared, supervision may be fulfilled by the day-to-day instruction 

27 and review of the supervised individual by the ANP. 

28 An ANP is considered to be supervising the use of radioactive materials when directing 

29 personnel in the conduct of operations involving licensed materials. The ANP need not be 

30 present at all times during the use of such materials; however, the supervising ANP is 

31 responsible for ensuring that personnel under supervision have been properly trained and 

32 instructed. The supervising ANP is, therefore, responsible for the supervision of operations 

33 involving the use of radioactive materials, whether or not he or she is present. 

34 The NRC regulations do not relieve the licensee from complying with applicable 

35 U.S. Department of Health and Human Services, FDA, other Federal and State requirements 

36 governing radioactive drugs. From an NRC perspective, if the supervision requirements are 

37 met, it is permissible for the licensee to allow the supervised individual to prepare 

38 radiopharmaceuticals without the presence of the ANP; however, some States require that a 

39 pharmacist be physically present during the preparation and dispensing of pharmaceuticals, 

40 including radioactive drugs. It is the licensee’s responsibility to ensure that its practices comply 

41 with any additional State requirements concerning this issue. 
8-26 

1 Response from Applicant: No response from the applicant is necessary. Supervision will be 

2 reviewed during inspection. 

3 8.9 Item 9: Facilities and Equipment 

4 8.9.1 Facilities and Equipment for Radiopharmacies 

5 Regulations: 10 CFR 32.72(a)(2), 10 CFR 30.33(a)(2), 10 CFR 20.1406, 10 CFR 20.1101(b), 

6 10 CFR 20.1801, 10 CFR 20.1802, CFR 30.35 (g), 10 CFR Part 37, 10 CFR 37.5, 10 CFR 

7 37.49, 10 CFR 37.53 

8 Criteria: A radiopharmacy must demonstrate that it is a pharmacy. Facilities and equipment 

9 must be adequate to protect health and minimize danger to life or property, minimize the 

10 likelihood of contamination, keep exposures to workers and the public ALARA, and provide 

11 enhanced physical protection of aggregated Category 1 and Category 2 quantities of radioactive 

12 material, as defined in 10 CFR 37.5. In addition, licensed materials must be secured from 

13 unauthorized access and removal. 

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

Category 2 quantity of radioactive material must, among other things, 

 implement the physical protection requirements in 10 CFR Part 37 for material in use 

and storage, at permanent jobsites; and 

 in accordance with 10 CFR 37.49, be able to monitor, detect with delay, assess, and 

respond to any unauthorized entries into security zones, including those surrounding 

mobile devices, and immediately detect any unauthorized removal of Category 1 

quantities of radioactive material from the security zone. (Monitoring and detection 

systems may include, among other methods, monitored video surveillance systems and 

electronic devices for intrusion detection alarms.) 

 for mobile devices containing Category 1 or Category 2 quantities of radioactive 

material, have two independent physical controls to secure the material from 

unauthorized removal when the device is not under direct control and constant 

surveillance in accordance with 10 CFR 37.53. “Mobile device” is defined in 

10 CFR 37.5. 

For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best 

practices for protection of risk-significant radioactive material is available in NUREG–2166, 

“Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.” 

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection.

 
8-27 

1 Discussion: An applicant must demonstrate that it is a pharmacy by submitting evidence of at 

2 least one of the following: 

3  licensure as a pharmacy by a State Board of Pharmacy, or 

4  operation as a nuclear pharmacy within a Federal medical institution 

5 If the registration or license has not been issued by the State Board of Pharmacy at the time 

6 of application, the applicant may provide it at a later date, but before license issuance from 

7 the NRC. 

8 Applicants must provide the NRC with documentation demonstrating that their facilities and 

9 equipment provide sufficient engineering controls and barriers to protect the health and safety of 

10 the public and their employees. The facilities and equipment must also keep exposures to 

11 radiation and radioactive materials ALARA and minimize the risks from the uses of the types 

12 and quantities of radioactive materials. The applicant should provide clear delineations 

13 between its restricted and unrestricted areas through the use of barriers, postings, and 

14 worker instructions. 

15 Applicants may delay completing facilities and acquiring equipment until after the application 

16 review is completed, in case changes are required as a result of the application review. This 

17 also ensures the adequacy of the facilities and equipment before the applicant makes a 

18 significant financial commitment. In all cases, the applicant cannot possess or use licensed 

19 material until after the facilities are approved, equipment is procured, and the license is issued. 

20 It is important to note that applicants who plan to amend their license to add the use and 

21 distribution of high-energy gamma-/photon-emitting radionuclides, such as PET radionuclides, 

22 to their operations should ensure their facilities and equipment are adequate to handle the 

23 higher energy radiation. Most likely, applicants will need to add and/or replace shielding, modify 

24 ventilation and air filtration systems, and possibly modify the facility’s design to accommodate 

25 the higher energy radionuclides. 

26 Applicants are reminded that records important to decommissioning are required to be 

27 maintained in an identifiable location. For further information, see Section 8.5.2, “Financial 

28 Assurance And Recordkeeping For Decommissioning.” 

29 Response from Applicant: Applicants must provide the following: 

30  Copies of their registration or license from a State Board of Pharmacy as a pharmacy, 

31 or evidence that they are operating as a nuclear pharmacy within a Federal 

32 medical institution. 

33 Note: If the applicant’s particular activities are not recognized as the practice of commercial 

34 radiopharmacy, the applicant must submit evidence that it is registered or licensed with the 

35 State or FDA as a drug manufacturer. Refer to NUREG-1556, Volume 12, “Program-Specific 

36 Guidance About Possession Licenses for Manufacturing and Distribution” for guidance on drug 

37 manufacturer requirements. 

38 AND 

39  Description of the facilities and equipment should be made available at each location 

40 where radioactive material will be used. A diagram(s) should be submitted showing the 
8-28 

1 applicant’s entire facility and identifying activities conducted in all contiguous areas 

2 surrounding the facility (see Figure 8-2). Diagrams should be drawn to a specified scale, 

3 or dimensions that are indicated. 

4 AND

5  The diagram(s) should also include: (1) descriptions of the area(s) assigned for the 

6 receipt, storage, preparation, and measurement of radioactive materials and the 

7 location(s) for radioactive waste storage; (2) sufficient detail in the diagram to indicate 

8 locations of shielding, the proximity of radiation sources to unrestricted areas, and other 

9 items related to radiation safety; (3) a general description of the ventilation system, 

10 including representative equipment such as glove boxes or fume hoods (Note: Pertinent 

11 airflow rates, differential pressures, filtration equipment, and monitoring systems should 

12 be described in terms of the minimum performance to be achieved); (4) confirmation that 

13 such systems will be employed for the use or storage of radioactive materials likely to 

14 become airborne, such as compounding radioiodine capsules and dispensing 

15 radioiodine solutions; (5)verification that ventilation systems ensure that effluents are 

16 ALARA, are within the dose limits of 10 CFR 20.1301, “Dose limits for individual 

17 members of the public,” and are within the ALARA constraints for air emissions 

18 established under 10 CFR 20.1101(d); and (6) marked drawings, diagrams, and 

19 descriptions that provide the exact location of materials or depict specific locations of 

20 security equipment as, “Security-Related Information—Withhold under 10 CFR 2.390”. 

21 Reference: For further information on facility design, see Chapter 4 of NCRP Report No. 127, 

22 “Operational Radiation Safety Program.” 
8-29 

*For the purposes of this NUREG, this diagram is marked appropriately for an application. This particular diagram is 

an example only and does not contain real security-related information.

Figure 8-2. Typical Radiopharmacy Diagram 

1 8.9.2 Facilities and Equipment for PET Radiopharmacies 

2 Regulations: 10 CFR 32.72(a)(2), 10 CFR 30.33(a)(2), 10 CFR 20.1406, 10 CFR 20.1101(b), 

3 10 CFR 30.35 (g) 

4 Criteria: PET radiopharmacies must demonstrate that they are registered with a State agency, 

5 are licensed as a pharmacy by the State’s Board of Pharmacy, or operate as a nuclear 

6 pharmacy within a Federal medical institution. Facilities and equipment must be adequate to 

7 protect health and minimize danger to life or property, minimize the likelihood of contamination, 

8 and keep exposures to workers and the public ALARA. 
8-30 

1 Discussion: In addition to the information required for a radiopharmacy, PET radiopharmacy 

2 applicants should describe the equipment and/or method and shielding used to physically 

3 transfer (e.g., transfer lines) PET radiochemicals to the chemical synthesis equipment for 

4 radiopharmaceutical manufacturing and then to the dispensing area. The description should 

5 also include shielding used for chemical synthesis and/or dispensing radiopharmaceuticals. 

6 Also, the type of remote handling equipment used for handling the PET radionuclides and drugs 

7 should be described. 

8 PET radiopharmacies should implement proper engineering controls due to the potential for 

9 radioactive air effluents produced during the chemical synthesis process. Examples of some 

10 engineering controls that should be used include exhaust filtration (e.g., high efficiency 

11 particulate air (HEPA) and carbon filters) and/or containment systems for decay of effluents. In 

12 addition, a continuous “real-time” effluent (stack) monitor should be installed at the facility. 

13 Appendix O of this NUREG provides guidance on effluent monitoring. 

14 Response from Applicant: Applicants must provide the following: 

15  Copies of their registration or license as a pharmacy from a State Board of Pharmacy 

16 or evidence that they are operating as a nuclear pharmacy within a Federal 

17 medical institution. 

18 Note: If the applicant’s particular activities are not recognized as the practice of commercial 

19 radiopharmacy, the applicant must submit evidence that it is registered or licensed with the 

20 State or FDA as a drug manufacturer. Refer to NUREG-1556, Volume 12, “Program-Specific 

21 Guidance About Possession Licenses for Manufacturing and Distribution” for guidance on drug 

22 manufacturer requirements. 

23 AND 

24  Description of the facilities and equipment to be made available at each location where 

25 radioactive material will be used, which includes the method and shielding used to 

26 physically transfer licensed material (e.g., transfer lines) to the different processes 

27 (e.g., chemical synthesis, dispensing). 

28 Note: A diagram should be submitted that shows the applicant’s entire facility and identifies 

29 activities conducted in all contiguous areas surrounding the facility (see Figure 8-3). Diagrams 

30 should be drawn to a specified scale, or dimensions that are indicated. 

31 AND

32  The diagram(s) should also include: (1) descriptions of the area(s) assigned for the 

33 production or receipt, storage, preparation, measurement, and distribution of radioactive 

34 materials and the location(s) for radioactive waste storage; (2) sufficient detail in the 

35 diagram to indicate locations of shielding and/or shielding equipment (e.g., hot cells for 

36 positron-emitting radionuclides), the proximity of radiation sources to unrestricted areas, 

37 and other items related to radiation safety, such as remote handling equipment and area 

38 monitors; (3) a general description of the ventilation system, including representative 

39 equipment, such as glove boxes or fume hoods; and (4) verification that ventilation 

40 systems ensure that effluents are ALARA, are within the dose limits of 10 CFR 20.1301, 

41 and are within the ALARA constraints for air emissions established under 

42 10 CFR 20.1101(d). 
8-31 

*For the purposes of this NUREG, this diagram is marked appropriately for an application. This particular diagram is 

an example only and does not contain real security-related information. 

Figure 8-3. Typical PET Radiopharmacy Diagram 

 
8-32 

1 Note: Pertinent airflow rates, differential pressures, filtration equipment, and monitoring 

2 systems should be described in terms of the minimum performance to be achieved. Confirm 

3 that such systems will be employed for the production, use, or storage of radioactive materials.

4 8.10 Item 10: Radiation Safety Program 

5 8.10.1 Audit and Review of Program 

6 Regulations: 10 CFR 20.1101, 10 CFR Part 20 Subpart L, 10 CFR 37.33, 10 CFR 37.55 

7 Criteria: Licensees that are subject to the requirements in 10 CFR Part 37 must annually 

8 review their access authorization program and security program. Licensees must review 

9 the content and implementation of their Radiation Protection Programs annually to ensure 

10 the following: 

11  compliance with NRC and DOT regulations (as applicable) and the terms and conditions 

12 of the license 

13  occupational doses and doses to members of the public are ALARA (10 CFR 20.1101, 

14 “Radiation protection programs”) 

15  records of audits and other reviews of program content are maintained for 3 years after 

16 the record is made 

17 Discussion: Appendix F of this NUREG contains an audit and review of program that is 

18 specific to commercial radiopharmacies and is acceptable to the NRC. All areas indicated in 

19 Appendix F of this NUREG may not be applicable to every licensee and may not need to be 

20 addressed during each audit. 

21 The NRC encourages licensee management to conduct performance-based reviews by 

22 observing work in progress, interviewing staff, and spot-checking required records. As part of 

23 the audit and review of program, licensees should consider including unannounced audits of 

24 fixed-gauge users to observe whether radiation safety procedures are being followed. 

25 It is essential that when problems are identified, comprehensive corrective actions are taken in a 

26 timely manner. Information Notice (IN) 96-28, “Suggested Guidance Relating to Development 

27 and Implementation of Corrective Action,” dated May 1, 1996, provides guidance on this 

28 subject. The NRC routinely reviews licensee’s records to verify whether appropriate corrective 

29 actions were implemented in a timely manner to address recurrence. It is in the best interest of 

30 the licensee to identify potential violations of regulatory requirements and take necessary steps 

31 to correct them. The NRC can opt to exercise discretion and may elect not to cite the licensee 

32 for these violations if prompt and effective corrective actions are implemented. The NRC’s 

33 Enforcement Policy may be found online at http://www.nrc.gov/about34 nrc/regulatory/enforcement/enforce-pol.html, and the Enforcement Manual may be found online 

35 at http://www.nrc.gov/about-nrc/regulatory/enforcement/guidance.html. For examples of the 

36 NRC’s use of discretion in issuing a notice of violation, refer to the most recent version of NRC’s 

37 enforcement documents at http://www.nrc.gov/reading-rm/doc-collections/enforcement/. 

38 With regard to audit records, 10 CFR 20.2102 requires, in part, that licensees maintain records 

39 of “audits and other reviews of program content and implementation” for 3 years after the record 

40 is made. The NRC has found audit records that contain the following information to be 
8-33 

1 acceptable: date of audit, name of person(s) who conducted the audit, persons contacted by 

2 the auditor(s), areas audited, audit findings, corrective actions, and followup. 

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

Category 2 quantity of radioactive material must, among other things, 

 in accordance with 10 CFR 37.33, review its access authorization programs at least 

annually to confirm compliance with the requirements of Subpart B of 10 CFR Part 37 

and ensure that comprehensive actions are taken to correct any noncompliance that 

is identified; and 

 in accordance with 10 CFR 37.55, review its security program at least annually to 

confirm compliance with the requirements of Subpart C of 10 CFR Part 37 and ensure 

that comprehensive actions are taken to correct any noncompliance that is identified. 

For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best 

practices for protection of risk-significant radioactive material is available in NUREG–2166, 

“Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.” 

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection.

3 Response from Applicant: No response is required. The licensee’s program for auditing its 

4 Radiation Safety Program will be reviewed during inspection. 

5 References: 

6 Inspection Procedure (IP) 87127 “Radiopharmacy Programs” August 2008 

7 NRC Enforcement guidance and policy 

8 IN 96-28, “Suggested Guidance Relating to Development and Implementation of Corrective 

9 Action,” dated May 1, 1996 

10 These references are available online at http://www.nrc.gov/. 

11 8.10.2 Radiation Monitoring Instruments 

12 Regulations: 10 CFR 20.1101, 10 CFR 20.1501, 10 CFR 20.2103(a), 10 CFR 30.33(a)(2) 

13 Criteria: Licensees must possess radiation monitoring instruments for the evaluation, 

14 detection, and measurement of possible radiation hazards that may be present. Instruments 

15 used for quantitative radiation measurements must be calibrated periodically for the 

16 radiation measured. 

17 Discussion: Licensees shall possess calibrated and operable radiation instruments to detect 

18 and measure radiation levels, radioactive contamination, and radioactivity, as applicable. 

19 Appropriate instruments must be available for use at all times when byproduct material is in use. 

20 The licensee should possess radiation monitoring instruments sufficiently sensitive to measure 
8-34 

1 the type and energy of radiation used. Radiation detection and measurement instruments 

2 should be used for radiation protection activities, including: 

3  package preparation and receipt surveys 

4  personnel and facility contamination measurements 

5  sealed source leak tests 

6  air sampling measurements 

7  bioassay measurements 

8  effluent release measurements 

9  dose rate surveys 

10 For the purposes of this document, radiation monitoring instruments are defined as any device 

11 used to measure the radiological conditions at a licensed facility. Some types of instruments 

12 that may be used to perform the above functions include 

13  portable or stationary count rate meters 

14  portable or stationary dose rate or exposure rate meters 

15  area monitors 

16  liquid scintillation counter (LSC) 

17  well-type scintillation counters 

18  stack monitors 

19  continuous air monitors 

20  hand and foot contamination monitors 

21 The choice of instrument should be appropriate for the type of radiation to be measured and for 

22 the type of measurement to be taken (e.g., count rate, dose rate). Radiopharmacies typically 

23 use a broad energy range of gamma and beta radiation emitters and need to use radiation 

24 detectors appropriate for those energies. Additionally, some radiopharmacies may handle or 

25 distribute alpha-emitting radiopharmaceuticals. Applicants should discuss the types of 

26 instruments to be used for each type of survey or measurement to be performed and the 

27 availability of a sufficient quantity of these instruments at their facility. 

28 Instrument calibrations may be performed by the radiopharmacy or by another person 

29 specifically authorized by the NRC or an Agreement State to perform that function. If the 

30 applicant wishes to calibrate its instruments, it must develop, implement, and maintain written 

31 radiation survey meter calibration procedures to ensure that instruments are properly calibrated. 

32 If the applicant chooses to use the services of another person for instrument calibration, the 

33 applicant should ensure that person has been authorized by either the NRC or an Agreement 

34 State to perform that activity. Regardless of whether an applicant is authorized to calibrate 

35 radiation survey meters or contracts an authorized firm to perform calibrations, the licensee 

36 must retain records of the calibration of instruments and equipment used for quantitative 

37 radiation measurements for 3 years after the record is made, in accordance with 

38 10 CFR 20.2103(a). Appendix G of this NUREG, “General Radiation Monitoring Instrument 

39 Selection Guidelines and Instrument Calibration Guidelines,” provides general instrument 

40 selection guidelines and instrument calibration guidelines. 
8-35 

1 Response from Applicant: Provide the following: 

2  A statement that, “We will use calibrated and operable equipment that is capable of 

3 detecting the type(s) of radiation being monitored (e.g., gamma, beta, alpha) and the 

4 energy or energy range of the radiation being measured.” 

5 OR 

6  A description of the calibrated and operable instrumentation that will be used to perform 

7 radiation monitoring (e.g., portable or stationary count rate meters, LSCs, well-type 

8 scintillation counters, air monitors). 

9 AND 

10  A statement that, “We reserve the right to upgrade our monitoring instrumentation as 

11 necessary, as long as the instruments are adequate to measure the type of radiation and 

12 energy range of the radiation for which they are used.” 

13 AND 

14  If calibration is performed by a person or firm outside the applicant’s organization, 

15 specify that the calibration will be performed by an NRC or Agreement State licensee 

16 specifically authorized to perform instrument calibration as a service to other licensees. 

17 OR 

18  If the calibration is to be performed in-house, submit the instrument calibration procedure 

19 that will be used. Instrument calibration guidelines are included in Appendix G of this 

20 NUREG, and they may be used to assist with development of the instrument calibration 

21 procedure. In addition, identify the qualifications of the individuals who will perform 

22 the calibrations. 

23 8.10.3 Material Receipt and Accountability 

24 Regulations: 10 CFR 30.35(g), 10 CFR 20.1501(a), 10 CFR 20.2001, 10 CFR 20.1801, 

25 10 CFR 20.1802, 10 CFR 20.1906, 10 CFR 20.2207, 10 CFR 20.2201, 10 CFR 20.2207, 

26 10 CFR 30.41, 10 CFR 30.51, 10 CFR 37.49, 10 CFR 37.71, 10 CFR 37.75, 10 CFR 37.77

27 Criteria: Licensees must ensure the security and accountability of licensed material and must 

28 open packages safely. If required to comply with 10 CFR Part 37, licensees must: 

29  maintain records of receipt, transfer, and disposal of licensed material 

30  update transactions in the National Source Tracking System (NSTS), including 

31 performing annual inventory reconciliation, if applicable 

32  before transferring aggregated Category 1 or Category 2 quantities of radioactive 

33 material listed in Appendix A to 10 CFR Part 37, use NRC’s license verification system 

34 to verify that the recipient licensee is authorized to possess the radioactive material 
8-36 

1  preplan, coordinate, and provide advance notification of shipment of Category 1 

2 quantities of radioactive material and coordinate shipment of Category 2 quantities of 

3 radioactive material listed in Appendix A to 10 CFR Part 37 

4 Discussion: Licensees must track licensed materials from receipt (from another licensee or 

5 from its own radionuclide production operations) to disposal in order to ensure accountability; 

6 identify when licensed material could be lost, stolen, or misplaced; and ensure that possession 

7 limits listed on the license are not exceeded. Licensees exercise control over licensed 

8 material accountability by including the following items (as applicable) in their Radiation 

9 Protection Program: 

10  conducting physical inventories at intervals not to exceed 6 months (or some other 

11 interval justified by the applicant and approved by the NRC) to account for all sealed 

12 sources in accordance with license condition 

13  ordering and receiving licensed material 

14  opening packages 

15  maintaining material inventory within license possession limits 

16  transferring material, including distribution 

17  disposing of material 

18 Licensees are required to develop, implement, and maintain written procedures for safely 

19 opening packages in accordance with 10 CFR 20.1906, “Procedures for receiving and opening 

20 packages.” Some packages may require special procedures that take into consideration the 

21 type, quantity, or half-life of the nuclide being delivered. 

22 A model procedure for safely opening packages containing licensed materials is included in 

23 Appendix M of this NUREG, “Material Receipt and Accountability.” 

24 NRC regulations in 10 CFR 20.1906(b) and (c) state the requirements for monitoring packages 

25 containing licensed material. These requirements are described in Table 8-1, below. 

26 Under 10 CFR 20.1906(d), the licensee is required to immediately notify the final delivery carrier 

27 and NRC Operations Center when removable radioactive surface contamination exceeds the 

28 limit in 10 CFR 71.87(i); or external radiation levels exceed the limit in 10 CFR 71.47, “External 

29 radiation standards for all packages.” 

30 For aggregated Category 1 and Category 2 quantities of radioactive material, licensees must, 

31 according to 10 CFR 37.49(a)(1), continuously monitor and detect, without delay, all 

32 unauthorized entries into security zones. Additionally, for Category 1 quantities of radioactive 

33 material, 10 CFR 37.49(a)(3)(i) requires immediate detection of any attempted unauthorized 

34 removal of the radioactive material from the security zone. For Category 2 quantities of 

35 radioactive material, 10 CFR 37.49(a)(3)(ii) requires weekly verification through physical 

36 checks, tamper indicating devices, use, or other means to ensure that the radioactive material 

37 is present. 
8-37 

1 Licensees are required under 10 CFR 20.1801 and 20.1802 to secure radioactive materials 

2 from unauthorized removal or access while in storage in controlled or unrestricted areas and to 

3 control and maintain constant surveillance over licensed material that is in a controlled or 

4 unrestricted areas and is not in storage. Applicants should establish policies and procedures 

5 for ensuring accountability of licensed materials. Licensed materials should be tracked from 

6 receipt to transfer to ensure accountability at all times; to identify when licensed material may 

7 be lost, stolen, or misplaced; and to ensure that the possession limit stated on the license is 

8 not exceeded.

Category 1 and Category 2 sealed sources listed in Appendix E to 10 CFR Part 20 

(i.e., nationally tracked sources) must be tracked in the National Source Tracking System 

(NSTS) in accordance with 10 CFR 20.2207. The regulations in 10 CFR 20.2207 require that 

each licensee that manufactures, transfers, receives, disassembles, or disposes of a nationally 

tracked source shall complete and submit a National Source Tracking Transaction Report 

(NSTTR) to the NRC. The NSTTRs are maintained in the NSTS, a secure computer system 

that tracks Category 1 and Category 2 nationally tracked sources from the time they are 

manufactured or imported through the time of their disposal or export, or until the source activity 

decays to below Category 2.

9 Note: Licensees must reconcile the inventory of nationally tracked sources possessed by the 

10 licensee against that licensee’s data in the NSTS. This reconciliation must be conducted during 

11 the month of January in each year. Licensees must submit to the NSTS confirmation that the 

12 data in NSTS is correct by January 31 of each year.

There are additional security requirements for shipment and transfer of a Category 1 and 

Category 2 quantity of radioactive material listed in Appendix A to 10 CFR Part 37. Prior to 

transferring Category 1 or Category 2 quantities of radioactive material, licensees must use 

NRC’s license verification system (or contact the licensing authority) to verify that the recipient 

licensee is authorized to possess the radioactive material. Licensees that ship Category 1 or 

Category 2 quantities of radioactive material must preplan and coordinate such shipments in 

accordance with 10 CFR 37.75. Shipments of Category 1 quantities are also subject to the 

10 CFR 37.77 advance notification requirements. For additional guidance on 

implementing 10 CFR Part 37 requirements, see NUREG–2155, “Implementation Guidance 

for 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 Quantities of 

Radioactive Material.”” Additional information regarding best practices for protection of 

risk-significant radioactive material is available in NUREG–2166, “Physical Security Best 

Practices for the Protection of Risk-Significant Radioactive Material.” 

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection. 

 
8-38 

Table 8-1. Package Monitoring Requirements 

Package Contents Survey Type Survey Time*

Labeled (White I, 

Yellow II, Yellow III) 

Gas or Special Form 

Greater Than Type A 

Radiation Level As soon as practicable, 

but not later than 

3 hours after receipt of 

package 

Labeled (White I, 

Yellow II, Yellow III) 

Not Gas or Special Form 

Greater Than Type A 

Contamination 

and Radiation 

Level 

As soon as practicable, 

but not later than 

3 hours after receipt of 

package 

Labeled (White I, 

Yellow II, Yellow III) 

Gas or Special Form 

Less Than Type A 

None None 

Labeled (White I, 

Yellow II, Yellow III) 

Not Gas or Special Form 

Less Than Type A 

Contamination As soon as practicable, 

but not later than 

3 hours after receipt of 

package 

Not Labeled Licensed Material None None 

Damaged Licensed Material Contamination 

and Radiation 

Level 

As soon as practicable, 

but not later than 

3 hours after receipt of 

package 

*Assumes packages are received during normal working hours. If packages are received outside of normal 

working hours, the licensee has 3 hours after the beginning of the next work day to perform the required surveys. 

1 Licenses will normally contain specific conditions requiring the licensee to perform inventories 

2 and leak tests of sealed sources every 6 months. Because the leak tests require an individual 

3 to locate and work with the sealed source, records of leak tests may be used as part of an 

4 inventory and accountability program. Sources in storage that are used infrequently may not 

5 require leak testing every 6 months; however, the inventory must still be performed at the 

6 specified interval. 

7 With regard to unsealed licensed material, licensees use various methods (e.g., computer 

8 programs, manual ledgers, log books) to account for receipt, use, transfer, disposal, and 

9 radioactive decay. These methods help to ensure that possession limits are not exceeded. 

10 Receipt, inventory, transfer, and disposal records must be maintained for the times specified in 

11 Table 8-2. Typically, these records contain the following types of information: 

12  radionuclide and the activity (in units of becquerels or curies) of byproduct material in 

13 each sealed source 

14  manufacturer’s or distributor’s name, model number, and serial number (if appropriate) 

15 of each device containing byproduct material 

16  location of each sealed source and device 
8-39 

Table 8-2. Record Maintenance 

Type of Record How Long Record Must Be Maintained 

Receipt For as long as the material is possessed and for 3 years 

following the transfer or disposal of the material 

Inventory For 5 years from the date of the inventory in accordance with 

license conditions 

Transfer For 3 years after each transfer unless a specific requirement 

dictates otherwise 

Disposal Until the NRC terminates the license 

Important to Decommissioning* Until the site is released for unrestricted use 

*See Section 8.5.2, “Financial Assurance and Recordkeeping for Decommissioning,” for more details. 

1  for inventories, the date of the inventory, and name and signature of the individual 

2 conducting the inventory 

3  for materials transferred or disposed of, the date of the transfer or disposal, the name 

4 and license number of the recipient, and a description of the affected radioactive 

5 material (e.g., radionuclide, activity, manufacturer’s or distributor’s name and model 

6 number, serial number)

7 Material accountability records typically contain the following information: 

8  radionuclide and activity (in units of Bq or Ci), and date of measurement of 

9 byproduct material 

10  for each sealed source, manufacturer, model number, location and serial number and as 

11 appropriate, manufacturer and model number of device containing the sealed source 

12  date of the transfer and name and license number of the recipient, and description of the 

13 radioactive material (e.g., radionuclide, activity, manufacturer’s name and model 

14 number, serial number) 

15  for licensed materials disposed of as waste, the radionuclide, activity, date of disposal, 

16 and method of disposal (e.g., decay, sewer) 

17 See Section 8.11, “Waste Management” for additional information. 

Information about locations where licensed material is used or stored is among the records 

important to decommissioning and required by 10 CFR 30.35(g). Also see Section 8.5.2, 

“Financial Assurance and Recordkeeping for Decommissioning.” 

18 Response from Applicant: Provide the following statements: 

19  “We will develop, implement, and maintain written procedures for safely opening 

20 packages that meet the requirements in 10 CFR 20.1906.” 

21 AND 

22  “We will conduct physical inventories of sealed sources of licensed material at intervals 

23 not to exceed 6 months.” 
8-40 

1 AND 

2  “We will develop, implement, and maintain written procedures for licensed material 

3 accountability and control to ensure that: 

4 — license possession limits are not exceeded 

5 — licensed material in storage is secured from unauthorized access or removal 

6 — licensed material not in storage is maintained under constant surveillance 

7 and control 

8 — records of receipt, either from the licensee’s own production operations or from 

9 another licensee transfer, and disposal of licensed material, are maintained.” 

10 AND 

11  If applicable, provide that following statement: “We will comply with the NSTS reporting 

12 requirement as described in 10 CFR 20.2207.” 

13 8.10.4 Occupational Dose 

14 Regulations: 10 CFR 19.13, 10 CFR 20.1201, 10 CFR 20.1202, 10 CFR 20.1203, 

15 10 CFR 20.1204, 10 CFR 20.1207, 10 CFR 20.1208, 10 CFR 20.1501, 10 CFR 20.1502, 

16 10 CFR 20.1703, 10 CFR 20.2104, 10 CFR 20.2106, 10 CFR 20 Appendix B

17 Criteria: Licensees must evaluate the potential occupational exposure of all workers and 

18 monitor occupational exposure. 

19 The use of individual monitoring devices for external dose is required, pursuant to 

20 10 CFR 20.1502(a), for 

21  adults who are likely to receive an annual dose from sources external to the body in 

22 excess of any of the following (each evaluated separately): 

23 — 5 mSv [0.5 rem] deep-dose equivalent 

24 — 15 mSv [1.5 rems] lens (of the eye) dose equivalent 

25 — 50 mSv [5 rems] shallow-dose equivalent to the skin 

26 — 50 mSv [5 rems] shallow-dose equivalent to any extremity 

27  minors who are likely to receive an annual dose from sources external to the body in 

28 excess of any of the following (each evaluated separately) 

29 — mSv [0.1 rem] deep-dose equivalent 

30 — 1.5 mSv [0.15 rem] lens (of the eye) dose equivalent 

31 — 5 mSv [0.5 rem] shallow-dose equivalent to the skin 

32 — 5 mSv [0.5 rem] shallow-dose equivalent to any extremity 

33  declared pregnant women who are likely to receive a dose from radiation sources 

34 external to the body during the entire pregnancy in excess of 1.0 mSv [0.1 rem] 

35 deep-dose equivalent 
8-41 

Total effective dose equivalent (TEDE) equals the effective dose equivalent (for external 

exposures) plus the committed effective dose equivalent (for internal exposures). 

1  individuals entering a high or very high radiation area 

2 Internal exposure monitoring is required, pursuant to 10 CFR 20.1502(b), for the following: 

3  adults likely to receive, in a year, an intake in excess of 10 percent of the applicable 

4 annual limit on intake for ingestion and inhalation 

5  minors likely to receive, in a year, a committed effective dose equivalent in excess of 

6 1.0 mSv [0.1 rem] and declared pregnant women likely to receive, during the entire 

7 pregnancy, a committed effective dose equivalent in excess of 1 mSv [0.1 rem] 

Figure 8-4. Annual Dose Limits for Adult Radiation Workers 

8 Discussion: If an adult radiation worker is likely to receive in a year a dose greater than 

9 10 percent of any applicable limit (See Figure 8-4 for annual dose limits), monitoring for 

10 occupational exposure is required. Monitoring is required for minors and declared pregnant 

11 females as shown in the criteria section. The licensee should perform an evaluation of the dose 

12 the individual is likely to receive prior to allowing the individual to receive the dose. This 

13 evaluation need not be made for every individual; evaluations can be made for employees with 

14 similar job functions or work areas. 

15 If this prospective evaluation shows that an adult individual’s dose is not likely to exceed 

16 10 percent of any applicable limit, there are no recordkeeping or reporting requirements in 

17 regard to the individual’s exposure. For individuals who have received doses at other facilities 

18 in the current year, the previous dose need not be considered in this prospective evaluation. 

19 Only the dose that could be received at the facility performing the evaluation need be 

20 considered when determining the need for monitoring, and therefore, recordkeeping and 

21 reporting requirements. If it was determined that monitoring was not required and a subsequent 

22 evaluation shows that the 10 percent threshold has or will be exceeded, the dose received when 

23 monitoring was not provided should be estimated, recorded, and reported. These estimates can 

24 be based on any combination of work location radiation monitoring or survey results, monitoring 
8-42 

1 results of individuals in similar work situations, or other estimates to produce a “best estimate” of 

2 the actual dose received. 

3 Licensees should use NRC Form 4, “Cumulative Occupational Dose History,” and NRC Form 5, 

4 “Occupational Dose Record for a Monitoring Period,” to record individual dose. If monitoring is 

5 not required to demonstrate compliance with all limits but is required relative to one or more 

6 specific limits, the licensee should enter “N/A” for “not applicable” in the blocks on NRC Form 4, 

7 “Cumulative Occupational Dose History,” and NRC Form 5, “Occupational Dose Record for a 

8 Monitoring Period,” to indicate the areas for which monitoring was not required (e.g., extremity 

9 or skin doses). Where monitoring was provided but not measurable, the licensee should enter 

10 “ND” for “not detectable.” 

11 If the prospective evaluation shows that the individual adult is likely to exceed 10 percent of an 

12 applicable limit, then monitoring and reporting of the results of monitoring performed—

13 regardless of the actual dose received—is required. If air sampling or bioassay is required, 

14 discussion of air sampling or bioassay should provide enough detail so that the NRC staff is 

15 assured that appropriate steps will be taken to manage and monitor such exposure. Licensees 

16 must provide individual radiation exposure data to each worker as required by 10 CFR 19.13. 

17 Licensees should also perform prospective evaluations of the doses that may be received by 

18 occupationally exposed minors and declared pregnant women. As with individual adult workers, 

19 licensees must supply and require the use of individual monitoring devices to monitor external 

20 exposures and monitor the occupational intake of radioactive material when the results of 

21 prospective dose evaluations exceed the doses specified in 10 CFR 20.1502. 

22 When personnel dosimeters that require processing to determine the radiation dose are used to 

23 comply with the individual monitoring requirement for external doses in 10 CFR 20.1502(a), 

24 licensees must use dosimeters supplied by a National Voluntary Laboratory Accreditation 

25 Program (NVLAP)-approved processor. The exchange frequency for dosimeters is typically 

26 monthly or quarterly. Applicants should consult with their NVLAP-approved processor for its 

27 recommendations for exchange frequency and proper use of the dosimeter. 

28 For guidance about methodologies for determination of internal occupational dose and 

29 summation of occupational dose, refer to Table 8-3. 

30 Additional Reference for Further Reading: 

31 U.S. Department of Energy G 441.1-1C, “Radiation Protection Programs Guide,” May 19, 2008 

32 Response from Applicant: Provide one of the following statements:

33 “We will maintain, for inspection by the NRC, documentation demonstrating that unmonitored 

34 individuals are not likely to receive a radiation dose in excess of the limits in 10 CFR 20.1502.” 

35 OR 

36 “We will monitor individuals in accordance with the criteria in the section titled, ‘Radiation Safety 

37 Program–Occupational Dose’ in NUREG–1556, Vol. 13, Rev. 2, “Consolidated Guidance About 

38 Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses.” 

 
8-43 

Table 8-3. Guidance on Personnel Monitoring and Bioassay 

Regulatory Guide 8.7, Revision 2 Instructions for Recording and Reporting Occupational 

Radiation Exposure Data 

Regulatory Guide 8.9, Revision 1 Acceptable Concepts, Models, Equations, and 

Assumptions for a Bioassay Program 

Regulatory Guide 8.20, Revision 2 Applications of Bioassay for Radioiodine 

Regulatory Guide 8.21, Revision 1 Health Physics Surveys for Byproduct Material at 

NRC-Licensed Processing and Manufacturing Plants 

Regulatory Guide 8.23, Revision 1 Radiation Safety Surveys at Medical Institutions 

Regulatory Guide 8.25, Revision 1 Air Sampling in the Workplace 

Regulatory Guide 8.32 Criteria for Establishing a Tritium Bioassay Program 

Regulatory Guide 8.34 Monitoring Criteria and Methods to Calculate Occupational 

Radiation Doses 

Regulatory Guide 8.35, Revision 1 Planned Special Exposures 

Regulatory Guide 8.36 Radiation Dose to the Embryo/Fetus 

Regulatory Guide 8.37 ALARA Levels for Effluents from Materials Facilities 

ANSI N13.30-2011 Performance Criteria for Radiobioassay 

Information Notice 2000-10 Recent Events Resulting in Extremity Exposures 

Exceeding Regulatory Limits 

1 OR, IN LIEU OF THESE STATEMENTS, 

2 Provide a description of an alternative method for demonstrating compliance with the 

3 referenced regulations. 

4 Reference: The National Institute of Standards and Technology (NIST) maintains a directory of 

5 laboratories that are NVLAP-approved at http://ts.nist.gov/standards/scopes/dosim.htm. 

6 8.10.5 Public Dose 

7 Regulations: 10 CFR 20.1101(d), 10 CFR 20.1301, 10 CFR 20.1302, 10 CFR 20.1801, 

8 10 CFR 20.1802, 10 CFR 20.2107, 10 CFR 20.2203, 10 CFR 20.2205 

9 Criteria: Licensees must do the following to prevent or minimize dose to members of 

10 the public: 

11  Ensure that licensed material will be used, transported, stored, and disposed of in such a 

12 way that members of the public will not receive more than 1 mSv [100 mrem] (TEDE) in 

13 a year from licensed activities. 

14  Ensure that the radiation dose in any unrestricted area will not exceed 0.02 mSv 

15 [2 mrem] in any 1 hour, from licensed activities. 
8-44 

1  Ensure that air emissions of radioactive material to the environment will not result in a 

2 TEDE in excess of 0.1 mSv [10 mrem] to individual members of the public in a year from 

3 those emissions. 

4  Prevent unauthorized access, removal, or use of licensed material. 

5 Discussion: Public dose is defined in 10 CFR Part 20 as “the dose received by a member of 

6 the public from exposure to radiation or to radioactive material released by a licensee, or to any 

7 other source of radiation under the control of a licensee.” Public dose excludes doses received 

8 from background radiation and medical procedures. Whether the dose to an individual is an 

9 occupational dose or a public dose depends on the individual’s assigned duties. It does not 

10 depend on the area (restricted, controlled, or unrestricted) where the individual is when he or 

11 she receives the dose. 

12 There are many possible exposure pathways that can contribute to public dose. The three 

13 major exposure pathways that can contribute to dose are 

14 (i) Airborne radioactive effluents 

15 (ii) Liquid radioactive effluents 

16 (iii) External (direct) radiation exposure 

17 The licensee should review these major pathways and decide which are applicable to its 

18 operations. The licensee must ensure that the TEDE from all exposure pathways 

19 (including direct radiation, liquid effluents, and airborne effluents) arising from licensed activities 

20 does not exceed 1.0 mSv [100 mrem] to the maximally exposed member of the public. In 

21 addition, the licensee must ensure that the fraction of the public dose limit allocated to airborne 

22 emissions is ALARA. This is accomplished by the licensee’s control of its air emissions, such 

23 that the individual member of the public likely to receive the highest dose will not be expected to 

24 receive a TEDE in excess of 0.1 mSv [10 mrem] per year from those emissions. In accordance 

25 with 10 CFR 20.2203, “Reports of exposures, radiation levels, and concentrations of radioactive 

26 material exceeding the constraints or limits,” if the dose limits for an individual member of the 

27 public are exceeded or if the licensee exceeds the constraint on airborne emissions, the 

28 licensee is required to make a report to the NRC and take prompt corrective actions to ensure 

29 against recurrence. 

30 Licensees should design a monitoring program to ensure compliance with 10 CFR 20.1101(d) 

31 and 10 CFR 20.1302(b). The extent and frequency of monitoring will depend upon each 

32 licensee’s scope and extent of licensed activities. For additional guidance regarding monitoring 

33 of effluents, refer to Section 8.10.7, “Surveys.” 

34 During NRC inspections, licensees must be able to provide documentation demonstrating, by 

35 measurement or calculation, that the TEDE to the individual member of the public likely to 

36 receive the highest dose from licensed operations does not exceed the annual limit and 

37 the dose constraint. See Appendix H of this NUREG for examples of methods to 

38 demonstrate compliance. 

39 Response from Applicant: No response is required from the applicant in a license application, 

40 but records demonstrating compliance will be examined during inspection. 
8-45 

1 References: 

2 RG 4.20, Rev. 1, “Constraint on Releases of Airborne Radioactive Materials to the Environment 

3 for Licensees Other Than Power Reactors,” April 2012 

4 RG 8.37, “ALARA Levels for Effluents from Materials Facilities,” July 1993 

5 8.10.6 Safe Use of Radionuclides and Emergency Procedures 

6 Regulations: 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.1902, 

7 10 CFR 20.1903, 10 CFR 20.1904, 10 CFR 20.1905, 10 CFR 20.2201, 10 CFR 20.2202, 

8 10 CFR 20.2203, 10 CFR 30.34(g), 10 CFR 30.50, 10 CFR 19.11(a)(3), 10 CFR 37 (Subpart B), 

9 10 CFR 37.21(a), 10 CFR 37.45, 10 CFR 37.49 

10 Criteria: Licensees that possess an aggregated Category 1 or Category 2 quantity of 

11 radioactive material, listed in Appendix A to 10 CFR Part 37, must also establish, implement, 

12 and maintain its access authorization program; coordinate, to the extent practicable, with local 

13 law enforcement authorities, for responding to threats to the licensee’s facility; and be able to 

14 monitor, detect without delay, assess, and respond to any unauthorized entries into 

15 security zones. 

16 Licensees are required to do the following: 

17  Keep radiation doses to workers and members of the public ALARA. 

18  Ensure security of licensed material. 

19  Make the required notifications of incidents to the NRC. 

20 Discussion: Licensees are responsible for the security and safe use of all licensed material 

21 from the time it arrives or is produced at their facility until its use, transfer, and/or disposal. 

22 Licensees should develop written procedures to ensure safe use of licensed material, and the 

23 procedures should also include operational and administrative guidelines. The written 

24 procedures should provide reasonable assurance that only appropriately trained personnel will 

25 handle and use licensed material without undue hazard to workers, members of the public, and 

26 the environment. 

27 All licensed materials stored in controlled or unrestricted areas must be secured from 

28 unauthorized access or removal so that individuals who may not be knowledgeable about 

29 radioactive materials cannot be exposed to or contaminated by the material, and so that 

30 individuals cannot take the material. When any licensed materials are in use in controlled or 

31 unrestricted areas, they must be under constant surveillance so that the radiation worker can 

32 prevent others from becoming contaminated by or exposed to the material and prevent 

33 unauthorized persons from removing the material from the area. 

34 Licensees should develop procedures that clearly state acceptable methods to secure licensed 

35 material at a facility. Particular attention may be required at facilities that have unusual needs 

36 because of the activities performed, such as hot cells and waste processing facilities. 
8-46 

1 General Safety Procedures

2 The written procedures should include the following elements: 

3  contamination controls 

4  waste disposal practices 

5  personnel and area monitoring (including limits) 

6  use of protective clothing and equipment 

7  safe handling of radioactive materials 

8  recording requirements 

9  reporting requirements 

10  responsibilities 

11 These procedures should include policies for: 

12  frequency of personnel monitoring 

13  performing molybdenum-99 breakthrough measurements of each eluate of a 

14 molybdenum-99/technetium-99m generator 

15  use of appropriate shielding (see Figure 8-5) 

16  use of personal protective equipment, such as lab coats and frequent glove changes to 

17 minimize exposure to the individual and to avoid spread of contamination in the facility 

18  special procedures for higher risk activities, such as use of radioiodine and repair of 

19 chemistry synthesis equipment for PET radiopharmaceuticals 

Figure 8-5. Use of Appropriate Shielding in a Fume Hood 

20 Applicants should also develop radionuclide-specific procedures based on the respective 

21 hazards associated with the radionuclides. General safety guidelines are described in 

22 Appendix N of this NUREG. Applicants should use these guidelines to aid in the development 

23 of their own procedures for the safe use of radionuclides. 
8-47 

1 Furthermore, applicants that produce radioactive materials using an accelerator should also 

2 refer to the safety procedures found in NUREG-1556, Volume 21, “Consolidated Guidance 

3 About Materials Licenses: Program-Specific Guidance About Possession Licenses for 

4 Production of Radioactive Material Using an Accelerator.” 

5 Licensees should determine if they have areas that require posting in accordance with 

6 10 CFR 20.1902, “Posting requirements,” unless they meet the exemptions listed in 

7 10 CFR 20.1903, “Exceptions to posting requirements.” Also, containers of licensed material 

8 (including radioactive waste) must be labeled in accordance with 10 CFR 20.1904, unless they 

9 meet the exemptions in 10 CFR 20.1905, “Exemptions to labeling requirements.”

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

Category 2 quantity of radioactive material must, among other things, 

 in accordance with 10 CFR 37.21(a), establish, implement, and maintain its access 

authorization program in accordance with the requirements of 10 CFR Part 37, 

Subpart B; 

 in accordance with 10 CFR 37.45, coordinate with their local law enforcement agency 

(LLEA) for responding to threats to a licensee’s facility; and 

 in accordance with 10 CFR 37.49, be able to monitor, detect without delay, assess, and 

respond to any unauthorized entries into security zones, including those surrounding 

mobile devices. 

For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best 

practices for protection of risk-significant radioactive material is available in NUREG–2166, 

“Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.” 

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection.

10 Emergency Procedures

11 Accidents and emergencies can happen during any operation with radionuclides, including their 

12 receipt, transportation, use, transfer, and disposal. Such incidents can result in contamination 

13 or release of material to the environment and unintended radiation exposure to workers and 

14 members of the public. In addition, loss or theft of licensed material and fires involving 

15 radioactive material, can adversely affect the safety of personnel and members of the public. 

16 Applicants should develop and implement procedures to minimize, to the extent practical, the 

17 potential impact of these incidents on personnel, members of the public, and the environment. 

18 Applicants should establish written procedures to handle events ranging from a minor spill to a 

19 major accident that may require intervention by outside emergency response personnel. These 

20 procedures should include provisions for immediate response, after-hours notification, handling 

21 of each type of emergency, equipment, and the appropriate roles of staff and the RSO. In 

22 addition, the licensee should develop procedures for routine contacts with its local fire 

23 department officials to inform them of its operations and identify locations of radioactive 

24 materials and elevated radiation levels in the event of their response to a fire. Except for minor 
8-48 

1 spills or releases of radioactivity that can be easily controlled and cleaned up by the user, 

2 licensee staff should have a clear understanding of their limitations in an emergency with 

3 step-by-step instructions and clear direction of whom to contact. The licensee should establish 

4 clear delineations between minor contamination events, minor spills, and major spills and 

5 events. An example of a minor spill is when low millicurie quantities of material with a short 

6 half-life in a nonvolatile liquid spills onto a nonabsorbent surface. 

7 Emergency spill response materials should be strategically placed in well-marked locations for 

8 use by all trained staff. All equipment should be periodically inspected for proper operation and 

9 replenished as necessary. Appendix N of this NUREG includes model emergency procedures. 

10 Applicants may adopt these procedures or develop their own, incorporating the safety features 

11 included in these model procedures. 

12 Certain incidents and emergencies are required to be reported to the NRC. Appendix Q of this 

13 NUREG, “NRC Incident Notifications,” provides a list of major NRC reporting and notification 

14 requirements relevant to commercial radiopharmacies. 

15 Response from Applicant: Submit the following statements: 

16 “We have developed and will implement and maintain written procedures for the safe and 

17 secure use of radioactive materials that address: 

18  facility and personnel radioactive contamination minimization, detection, and control 

19  performing molybdenum-99 breakthrough measurements on each eluate of a 

20 molybdenum-99/technetium-99m generator 

21  use of protective clothing and equipment by personnel that meet the requirements in 

22 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 30.34(g), and 

23 10 CFR 19.11(a)(3), as applicable.” 

24 AND 

25 “We have developed and will implement and maintain written procedures for identifying and 

26 responding to emergencies involving radioactive material, including: 

27  lost, stolen, or missing licensed material 

28  exposures to personnel and the public in excess of NRC regulatory limits 

29  releases of licensed materials in effluents and the sanitary sewer in excess of NRC 

30 regulatory limits 

31  excessive radiation levels or radioactive material concentrations in restricted or 

32 unrestricted areas 

33  radioactive spills and contamination 

34  fires, explosions, and other disasters with the potential for the loss of containment of 

35 licensed material 
8-49 

1  routine contacts with local fire departments and LLEA that meet the requirements in 

2 10 CFR 20.1101, 10 CFR 20.2201-2203 (“Reports of theft or loss of licensed material;” 

3 “Notification of reports of exposures, radiation levels, and concentrations of radioactive 

4 material exceeding the constraints or limits”), and 10 CFR 30.50, “Reporting 

5 requirements,” and other requirements, as applicable.” 

6 8.10.7 Surveys 

7 Regulations: 10 CFR 30.53, 10 CFR 20.1501, 10 CFR 20.2103 

8 Criteria: Licensees are required to make surveys of potential radiological hazards in their 

9 workplace. Records of survey results must be maintained. 

10 Discussion: Surveys are evaluations of radiological conditions and potential hazards 

11 (see Figure 8-6). These evaluations may be measurements (e.g., radiation levels measured 

12 with a survey instrument, wipe test removable contamination results), calculations, or a 

13 combination of measurements and calculations. The selection and proper use of appropriate 

14 instruments is one of the most important factors in ensuring that surveys accurately assess the 

15 radiological conditions. In order to meet regulatory requirements for surveying, measurements 

16 of radioactivity should be understood in terms of its properties (i.e., alpha, beta, gamma) and 

17 compared to the appropriate limits. 

Figure 8-6. Types of Surveys 

There are many different types of surveys performed by 

radiopharmacy licensees. 

 

RPh15a.ppt

082898

RSO

Types of

Surveys Types of

Surveys

• Contamination

– Fixed

– Removable

• Air Effluent

• Water Effluent

• Leak Test

• Bioassays

• Air Sample

• General Area

– Restricted

– Unrestricted
8-50 

1 Radiation surveys are used to detect and evaluate contamination of: 

2  facilities (restricted and unrestricted areas) 

3  equipment 

4  incoming and outgoing radioactive packages 

5  personnel (during and after use, transfer, or disposal of licensed material) 

6 (see Figure 8-7) 

Surveying arms and hands using 

radiation survey meter and 

beta/gamma probe 

Surveying feet and legs using 

radiation survey meter and 

beta/gamma probe 

Figure 8-7. Personnel Surveys 

Users of unsealed licensed material should check themselves for 

contamination (frisk) before leaving the restricted areas within the 

radiopharmacy.

7 Surveys are also used to plan work in areas where licensed material is used or stored and to 

8 evaluate doses to workers and individual members of the public. 

9 Surveys are required when it is reasonable under the circumstances to evaluate a radiological 

10 hazard and when necessary for the licensee to comply with the appropriate regulations. Many 

11 different types of surveys may need to be performed because of the particular use of licensed 

12 materials. Typical surveys may include the following: 

13  surveys for radioactive contamination that could be present on surfaces of floors, walls, 

14 laboratory furniture, and equipment 
8-51 

1  measurements of radioactive material concentrations in air for areas where 

2 radiopharmaceuticals are handled or processed in unsealed form and where operations 

3 could expose workers to the inhalation of radioactive material (e.g., radioiodine) or 

4 where licensed material is or could be released to unrestricted areas 

5  surveys of external radiation exposure levels in both restricted and unrestricted areas 

6 [Note: external radiation exposure surveys should be done with the survey instrument 

7 probe close to the surface being measured and moved slowly enough to allow the 

8 instrument to detect radiation (e.g., probe is a half-inch from the surface and moved 

9 2 inches per second)] 

10  surveys of radiopharmaceutical packages entering (e.g., from suppliers and returns 

11 from customers) and departing (e.g., prepared radiopharmaceuticals for shipment 

12 to customers) 

13 The frequency of routine surveys depends on the nature, quantity, and use of radioactive 

14 materials, as well as the specific protective facilities, equipment, and procedures that are 

15 designed to protect workers from external and internal exposure. Also, the frequency of the 

16 survey depends on the type of survey, such as those listed above. Appendix O of this NUREG, 

17 “Radiation Survey Guidelines,” contains additional radiation survey guidance. 

18 Not all instruments can measure a given type of radiation (e.g., alpha, beta, and gamma) or 

19 energy range of a particular radiation. The presence of other radiation may interfere with a 

20 detector’s ability to measure the radiation of interest. The energy of the radiation may not be 

21 high enough to penetrate some detector windows and be counted. The correct selection, 

22 calibration, and use of radiation detection instruments are important aspects of any Radiation 

23 Safety Program. 

24 Regulations in 10 CFR Part 20 specify dose limits for unrestricted areas (2 mrem in any 1 hour) 

25 and posting requirements (5 mrem in any 1 hour for “Radiation Areas”). Applicants should 

26 propose and justify their removable surface contamination and radiation level action limits that 

27 will require action to (i) reduce the contamination or radiation level, or (ii) institute additional 

28 restrictions on access to the area. 

29 Undetected Contamination and Loss of Control of Licensed Material

30 Because of the large quantities of licensed material in unsealed form often handled by 

31 radiopharmacy personnel, there can be a greater potential for radioactive material 

32 contamination. Radiation surveys, if properly conducted, will normally detect contamination 

33 before it leaves the licensee’s restricted area (e.g., radiopharmaceutical preparation and 

34 packaging areas). If detected within the restricted area during or shortly following 

35 radiopharmaceutical preparation, the licensee can normally complete standard decontamination 

36 activities to mitigate the spread of the contamination outside the restricted area. 

37 There have been several instances involving NRC licensees, including radiopharmacies, in 

38 which contamination has not been detected (usually due to no survey, or an inadequate survey, 

39 being performed) and has been inadvertently removed or released from the restricted area. 

40 Typically the contamination has been deposited on an outgoing package containing radioactive 

41 material, the skin or clothing of a licensee employee leaving the facility, or both. Once the 

42 contamination leaves the licensee’s restricted area, control of the radioactive material is lost. At 

43 this point, the contamination has a high probability of reaching public locations outside the 
8-52 

1 radiopharmacy, including one or more of its customers (e.g., a hospital). Contamination 

2 incidents such as this can create public health, regulatory, and public relations problems for 

3 licensees. In virtually all cases, the events could have been avoided if licensee personnel had 

4 performed an adequate radiation survey to detect the contamination before it left the restricted 

5 area. NRC IN 98-18, “Recent Contamination Incidences Resulting From Failure to Perform 

6 Adequate Surveys,” dated May 13, 1998, describes some such incidents involving NRC 

7 licensees, followed by a summary of NRC requirements to perform adequate and 

8 timely surveys. 

9 Response from Applicant: Submit the following statement: “We have developed and will 

10 implement and maintain written procedures for a survey program that includes: (1) performance 

11 of radiation and contamination level surveys in restricted and unrestricted areas; (2) personnel 

12 contamination monitoring; (3) action levels; (4) survey frequencies; and (5) maintenance of 

13 survey records that meet the requirements in 10 CFR 30.53, 10 CFR 20.1501, and 

14 10 CFR 20.2103, as applicable.” 

15 Reference: 

16 NRC IN 98-18, “Recent Contamination Incidences Resulting From Failure to Perform Adequate 

17 Surveys,” dated May 13, 1998, can be found at 

18 http://www.nrc.gov/reading-rm/doc-collections/gen-comm/info-notices/1998/in98018.html. 

19 8.10.8 Dosage Measurement Systems 

20 Regulation: 10 CFR 32.72(c) 

21 Criteria: Commercial radiopharmacy licensees must possess and use instrumentation capable 

22 of accurately measuring the radioactivity in radioactive drugs. 

23 Discussion: Because of the potential for radiopharmacy errors to adversely affect their 

24 customers (medical facilities) and their customers’ patients, each dosage of a radioactive drug 

25 must be measured before transfer to provide high confidence that the correct amount of the 

26 radioactive drug is transferred, in accordance with the customer’s request. 

27 The applicant must have procedures for the use of the instrumentation, including the 

28 measurement, by direct measurement or by a combination of measurement and calculation, of 

29 the amount of radioactivity in dosages of alpha-, beta-, gamma-, and photon-emitting radioactive 

30 drugs before their transfer for commercial distribution. 

31 These procedures must ensure that the dose calibrator, or other dose measurement system, 

32 functions properly. This is accomplished by performing periodic checks and tests before first 

33 use, followed by checks at specified intervals, and following repairs that could affect system 

34 performance. Equipment used to measure dosages that emit gamma, alpha, or beta radiation 

35 must be calibrated for the applicable radionuclide being measured. For photon-emitters, activity 

36 measurement is a fairly straightforward determination; however, for beta-emitters, a correction 

37 factor is often necessary to accurately determine the activity. There are inherent technical 

38 difficulties to overcome in the determination and application of beta-correction factors. These 

39 difficulties include dependence on geometry, lack of an industry standard for materials used in 

40 the manufacture of both vials and syringes, and lack of a NIST traceable standard for all 

41 radionuclides currently in use. If radiopharmacies intend to initially distribute (i.e., measure, 

42 prepare, and label) beta-emitting radionuclides, the applicant must provide the calculation to 
8-53 

1 demonstrate its ability to accurately dispense such materials. If the applicant intends to use 

2 beta-correction factors supplied by the instrument manufacturer, or other entity, it should include 

3 a means for ensuring the accuracy of the supplied factor. If radiopharmacy applicants intend to 

4 only redistribute beta-emitting radionuclides that have been previously prepared and distributed 

5 by other persons licensed pursuant to 10 CFR 32.72, then the correction factor calculation is not 

6 required. 

7 Licensees must assay patient dosages in the same type of vial and geometry as used to 

8 determine the correct dose calibrator settings. The use of different vials or syringes may result 

9 in measurement errors, for example, because of the variation of bremsstrahlung created by 

10 interaction between beta particles and the differing dosage containers. Licensees are reminded 

11 that beta emitters should be shielded using a low-atomic-numbered material to minimize the 

12 production of bremsstrahlung, followed by a high-atomic-numbered material thick enough to 

13 attenuate the bremsstrahlung intensity. 

14 For each dose measurement system, specific periodic tests must be performed, as appropriate 

15 to the system, to ensure correct operation. Typically, all systems must be checked each day of 

16 use for constancy to ensure continued proper operation of the system. As required by 

17 10 CFR 32.72(c)(1), tests for accuracy (for the activities across the range of energies 

18 measured), linearity (for the range of activities to be measured), and geometry dependence 

19 (for the range of volumes and types of containers to be measured) must be done periodically; 

20 therefore, the applicant must include the frequency for conducting these tests in its written 

21 procedures for the performance of dose measurement system checks and tests. 

22 The applicant should ensure that it possesses a sufficient number of such instruments to allow 

23 for periods when instruments are out of service for repair and calibration. 

24 Appendix L of this NUREG, “Dose Calibrator Testing Guidance,” contains guidance for dose 

25 calibrator testing. 

26 Response from Applicant: The applicant must describe the types of systems 

27 (measurement or combination of measurement and calculation) to be used for the 

28 measurement of alpha-, beta-, gamma-, and photon-emitting radioactive drugs. 

29 AND

30 For each dose measurement system used to measure the amount of radioactivity in alpha-, 

31 beta-, gamma-, and photon-emitting radioactive drugs, state: “We have developed and will 

32 implement and maintain, a written procedure for the performance of dose measurement system 

33 checks and tests that meets the requirements in 10 CFR 32.72(c).” 

34 AND

35 If applicable, the applicant must include a sample calculation for determining beta-correction 

36 factors for dose calibrators with ionization chambers. 

Radiopharmacies that intend to initially distribute (i.e., measure, prepare, and label) 

beta- emitting radionuclides must provide the calculation to demonstrate its ability to 

accurately dispense such materials; however, a correction factor calculation is not required if 

radiopharmacy applicants intend to only redistribute beta-emitting radionuclides that were 

previously prepared and distributed by others who are licensed pursuant to 10 CFR 32.72. 
8-54 

OR 

1 If applicable, the applicant must include a means for ensuring the accuracy of beta-correction 

2 factors supplied by the instrument manufacturer or other entity.

3 8.10.9 Transportation 

4 Regulations: 10 CFR 71.5, 10 CFR 71.12, 10 CFR 71.13, 10 CFR 71.14, 10 CFR 71.47, 

5 10 CFR 71.87, 49 CFR 107, 49 CFR 171-180, 49 CFR 390-397, 10 CFR 20.1101, 

6 10 CFR 30.41, 10 CFR 30.51, 10 CFR Part 37 (Subpart D) 

7 Criteria: Applicants who will prepare for shipment, ship, or transport radioactive materials, 

8 including radioactive waste, must develop, implement, and maintain safety programs for the 

9 transport of those materials to ensure compliance with NRC and DOT regulations. 

10 In accordance with 10 CFR Part 37 (Subpart D), licensees must also preplan, coordinate and 

11 provide advance notification of the shipment of Category 1 quantities of radioactive material and 

12 coordinate the shipment of Category 2 quantities of radioactive material. 

13 Discussion: In accordance with a memorandum of understanding (MOU) between DOT and 

14 NRC, the NRC inspects and enforces DOT’s regulations governing the transport of radioactive 

15 materials by NRC’s licensees. 

16 The types and quantities of radioactive materials shipped by a commercial radiopharmacy 

17 licensee will nearly always meet the criteria for shipment in a “Type A” package, as defined by 

18 DOT. The requirements for these packages include the provisions for shipping papers, 

19 packaging design standards, package marking and labeling, and radiation levels and 

20 contamination limits. For radiopharmacies who transport their own packages, the packages 

21 must be blocked and braced, and shipping papers must be used and located properly in the 

22 driver’s compartment. 

23 Packaging used by a commercial radiopharmacy typically includes nylon “briefcases” and 

24 cardboard/fiberboard boxes. These packages will normally meet the criteria for “Type A” 

25 quantities, which must meet specified performance standards to demonstrate that they will 

26 maintain the integrity of containment and shielding under normal conditions of transport. Such 

27 packages will normally withstand minor accident situations and rough handling conditions. 

28 The testing criteria for Type A packages are listed in 49 CFR 173.465, “Type A packaging 

29 tests,” and 49 CFR 173.466, “Additional tests for Type A packagings designed for liquids and 

30 gases.” Before offering a Type A package for shipment, the shipper is responsible for ensuring 

31 that the package has been tested to meet the criteria for the contents and the configuration to 

32 be shipped. In addition, the shipper must maintain records to furnish evidence of the quality of 

33 packaging for 3 years after the life of the packaging to which they apply. 

34 The DOT regulations also require that individuals who perform functions related to the 

35 packaging and shipment of radioactive material packages receive training specific to those 

36 functions. The training must include a general awareness of DOT requirements, 

37 function-specific training for the individuals’ duties, safety training, and security-awareness 

38 training. The DOT regulations also specify the frequency of the training and a record retention 

39 requirement for training (see Section 8.8.2, “Personnel Involved in Hazardous Materials 

40 Package Preparation and Transport). 
8-55 

1 An outline of DOT requirements generally relevant to a commercial radiopharmacy operation is 

2 included for applicant and licensee reference in Appendix J of this NUREG. 

Licensees shipping or transferring a Category 1 or Category 2 quantity of radioactive material 

are subject to the 10 CFR Part 37, Subpart D (“Physical Protection in Transit”). For additional 

guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, “Implementation 

Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 Quantities of 

Radioactive Material.”” Additional information regarding best practices for protection of 

risk-significant radioactive material is available in NUREG–2166, “Physical Security Best 

Practices for the Protection of Risk-Significant Radioactive Material.” 

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection. 

3 Response from Applicant: No response is required. The licensee’s program for 

4 transportation of radioactive materials will be reviewed during inspection. 

5 8.10.10 Minimization of Contamination 

6 Regulation: 10 CFR 20.1406 

7 Criteria: Applicants for new licenses must describe how facility design and procedures for 

8 operation will minimize, to the extent practicable, contamination of the facility and the 

9 environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the 

10 generation of radioactive waste. 

11 Discussion: All applicants for new licenses need to consider the importance of designing and 

12 operating their facilities to minimize the amount of radioactive contamination generated at the 

13 site during its operating lifetime and to minimize the generation of radioactive waste during 

14 decontamination. Commercial radiopharmacy applicants usually do not need to address 

15 these issues as a separate item, because they are included in responses to other items of 

16 the application. 

17 The majority of unsealed radioactive materials used by radiopharmacies have short physical 

18 half-lives (less than 120 days). Nearly all radioactive waste generated by radiopharmacies is 

19 stored for decay rather than transferred to a radioactive waste disposal facility. 

20 The licensee may possess and redistribute sealed sources that contain radionuclides with long 

21 half-lives. These sealed sources have been approved by the NRC or an Agreement State and, 

22 if used according to the respective SSD registration certificate, usually pose little risk of 

23 contamination. Leak tests performed at the frequency specified in the SSD registration 

24 certificate should identify defective sources. Leaking sources must be immediately withdrawn 

25 from use and decontaminated, repaired, or disposed of in accordance with the disposal 

26 requirements in Subpart K of 10 CFR Part 20. In addition, leaking sources must be contained to 

27 prevent the spread of contamination and reduce radioactive waste associated with 

28 decontamination efforts. For example, a leaking source may be contained by placing it in a 

29 plastic bag and sealing the bag closed while implementing actions to prevent contamination 

30 spread. The leaking sources must also be transferred to an authorized recipient or disposed of 

31 according to NRC requirements. 
8-56 

1 Response from Applicant: The applicant does not need to provide a response to this item 

2 under the following condition: NRC will consider that the criteria have been met if the 

3 applicant’s responses meet the criteria for the following sections of NUREG-1556, Volume 13: 

4 Section 8.9, “Facilities and Equipment;” Section 8.10.6, “Safe Use of Radionuclides and 

5 Emergency Procedures;” Section 8.10.7, “Surveys;” Section 8.10.13, “Leak Tests;” and 

6 Section 8.11, “Item 11: Waste Management.”

7 8.10.11 Radioactive Drug Labeling for Distribution 

8 Regulations: 10 CFR 20.1901, 10 CFR 20.1904, 10 CFR 20.1905, 10 CFR 30.34(g), and 

9 10 CFR 32.72(a)(4) 

10 Criteria: The labels affixed to radioactive drugs for distribution must have the required color, 

11 symbol, and wording. 

12 Discussion: The licensee must label each “transport radiation shield” to show the radiation 

13 symbol as described in 10 CFR 20.1901. The label must also include the words “CAUTION, 

14 RADIOACTIVE MATERIAL,” or “DANGER, RADIOACTIVE MATERIAL,” the name of the 

15 radioactive drug or its abbreviation, and the quantity of radioactivity at a specified date and time. 

16 The phrase “transport radiation shield” refers to the primary shield for the radioactive drug, 

17 which may include the syringe, vial, or syringe or vial shield. The “transport radiation shield” 

18 should be constructed of material appropriate for the isotope to be transferred for commercial 

19 distribution. The “transport radiation shield” does not refer to the outer suitcase, packaging, or 

20 other carrying device, even though that barrier may provide some radiation shielding. 

21 The licensee must label each syringe, vial, or other container (e.g., generator or ampoule) used 

22 to hold radioactive drugs to be transferred for commercial distribution to show the radiation 

23 symbol, as described in 10 CFR 20.1901. The label must include the words “CAUTION, 

24 RADIOACTIVE MATERIAL,” or “DANGER, RADIOACTIVE MATERIAL,” and an identifier that 

25 ensures the syringe, vial, or other container can be correlated with the information on the 

26 “transport radiation shield” label. The identifier must provide a correlation between the syringe, 

27 vial, or other container and the information on the label of its “transport radiation shield.” 

28 Identifiers may include the prescription number, the name of the radioactive drug or its 

29 abbreviation, the name of the patient, or the clinical procedure. 

30 Response from Applicant: The applicant must: 

31  describe all labels, indicating the colors to be used, that will accompany the products 

32 and describe where each label is placed (e.g., on the “transport radiation shield” or on 

33 the container used to hold the radioactive drug) 

34 AND

35  agree to affix the required labels to all “transport radiation shields” and to each container 

36 used to hold the radioactive drugs 
8-57 

1 8.10.12 Radioactive Drug Shielding for Distribution 

2 Regulations: 10 CFR 32.72(a)(3), 10 CFR 20.1201, 10 CFR 20.1207, 10 CFR 20.1208 

3 Criteria: The shielding provided for each radioactive drug to be distributed must be adequate 

4 for safe handling and storage by the pharmacy’s customers to maintain occupational 

5 exposures ALARA. 

6 Discussion: The applicant must provide appropriate “transport radiation shields” for the 

7 primary container of each radioactive drug that it intends to distribute. The shielding must be 

8 adequate for the types and quantities of radioactive materials that the applicant intends to 

9 distribute. Typically, “transport radiation shields” used by radiopharmacies have included 

10 two-piece, shielded syringe, and vial containers (or “pigs”). Pharmacies have used lead and 

11 tungsten shields for gamma-emitting materials and Plexiglas inserts for beta-emitters. 

12 “Transport radiation shields” for technetium-99m products generally ensure surface radiation 

13 levels of not more than 0.03 mSv/hr [3 millirem per hour (mrem/hr)], because of the ease of 

14 shielding the low-energy gamma emitted. For iodine-131, surface dose rates on “transport 

15 radiation shields” have been approved up to 0.5 mSv/hr [50 mrem/hr] for diagnostic dosages 

16 and up to 1.5 mSv/hr [150 mrem/hr] for therapeutic dosages. The applicant should select 

17 appropriate shielding materials and dimensions to ensure not only that occupational doses are 

18 ALARA, but also that the “transport radiation shield” can be easily handled. 

19 Response from Applicant: For each radioactive drug to be distributed (except for products 

20 intended for redistribution without manipulation and in the manufacturer’s original shipping 

21 package), provide the following: 

22  Indicate the radionuclide and the maximum activity for each type of container 

23 (e.g., vial, syringe). 

24  Describe the type and thickness of the “transport radiation shield” provided for each type 

25 of container. 

26  Indicate the maximum radiation level to be expected at the surface of each “transport 

27 radiation shield” when the radioactive drug container is filled with the maximum activity. 

28 Note: It is not acceptable to state that the applicant will comply with DOT regulations. The 

29 dose-rate limits that DOT imposes apply to the surface of the package, not the surface of the 

30 “transport radiation shield.” 

31 8.10.13 Leak Tests 

32 Regulations: 10 CFR 30.53, 10 CFR 20.1501, 10 CFR 20.2103 

33 Criteria: The NRC requires testing to determine whether there is any radioactive leakage from 

34 the sealed sources. Licensees must maintain records of leak test results in accordance with 

35 license conditions or, if applicable, NRC regulations. 

36 Discussion: When issued, a license will require performance of leak tests at intervals 

37 approved by NRC or an Agreement State and specified in the SSD registration certificate. The 
8-58 

1 measurement of the leak test sample is a quantitative analysis requiring that instrumentation 

2 used to analyze the sample be capable of detecting 185 Bq [0.005 microcuries] of radioactivity. 

3 Manufacturers, distributors, consultants, and other organizations may be authorized by the NRC 

4 or an Agreement State to either perform the entire leak test sequence on behalf of licensees or 

5 provide leak test kits to licensees. In the latter case, the licensee takes the leak test sample 

6 according to the manufacturer’s and/or the kit supplier’s instructions and returns it to the leak 

7 test service provider for evaluation and reporting results. Leak test samples should be collected 

8 at the most accessible area where contamination would accumulate if the sealed source were 

9 leaking. The NRC or an Agreement State may, in a license condition, specifically authorize 

10 radiopharmacy licensees to conduct the entire leak test sequence themselves. Measurement of 

11 the leak-test sample is a quantitative analysis requiring that instrumentation used to analyze the 

12 sample be capable of detecting 185 Bq [0.005 microcurie (μCi)] of radioactivity. 

13 Response from Applicant: State either of the following: 

14  “Leak test sample collection and analysis will be performed by an organization 

15 authorized by the NRC or an Agreement State to provide leak testing services to other 

16 licensees; or by using a leak test sample collection kit supplied by an organization 

17 licensed by the NRC or an Agreement State to provide leak test kits and sample analysis 

18 services to other licensees and according to the instructions provided in the leak test 

19 sample collection kit.” 

20 OR 

21  “Leak testing and analysis will be done by the applicant.” Provide the information in 

22 Appendix I of this NUREG supporting a request to perform leak testing and sample 

23 analysis and either state that the applicant will follow the model procedures in Appendix I 

24 of NUREG–1556, Volume 13, Revision 2, “Consolidated Guidance About Materials 

25 Licensees: Program-Specific Guidance About Commercial Radiopharmacy Licenses” or 

26 submit alternative procedures. 

27 Note: Requests for authorization to perform leak testing and sample analysis will be reviewed 

28 on a case-by-case basis and, if approved, the NRC staff will authorize these activities via a 

29 license condition. 

30 8.10.14 Security Program for Category 1 and Category 2 Radioactive Material 

31 Regulations: 10 CFR Part 37 

32 Criteria: Licensees must ensure the security of Category 1 and Category 2 

33 radioactive material. 

34 Note: The regulations in 10 CFR Part 37 apply to licensees that possess an aggregated 

35 Category 1 or Category 2 quantity of radioactive material. The specific radionuclides subject to 

36 10 CFR Part 37 requirements are listed in Table 1 of Appendix A to 10 CFR Part 37. 
8-59 

1 Discussion: 

2 Requirements in 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 Quantities 

3 of Radioactive Material” 

4 In accordance with 10 CFR Part 37, licensees that possess aggregated Category 1 or 

5 Category 2 quantities of radioactive material must establish, implement, and maintain an access 

6 authorization program (Subpart B) and a security program (Subpart C) to ensure physical 

7 protection of the radioactive material. 

8 Table 1 of Appendix A, “Category 1 and Category 2 Radioactive Materials,” to 10 CFR Part 37, 

9 lists Category 1 and Category 2 threshold quantities of radioactive material. The applicant 

10 should refer to this table to determine whether its proposed activities would be subject to the 

11 10 CFR Part 37 requirements. 

12 Before giving individuals unescorted access to Category 1 or Category 2 quantities of 

13 radioactive material (as defined in 10 CFR 37.5), licensees must conduct background 

14 investigations of these individuals, to determine that they are trustworthy and reliable, in 

15 accordance with 10 CFR 37.25. 

16 In accordance with 10 CFR 37.41(b), licensees must establish a security program designed to 

17 monitor and, without delay, detect, assess, and respond to any actual or attempted 

18 unauthorized access to Category 1 or Category 2 quantities of radioactive material. 

19 Per 10 CFR Part 37, Subpart D, licensees must provide for physical protection of Category 1 or 

20 Category 2 quantities of radioactive materials in transit. These requirements apply to licensees 

21 delivering such material to a carrier for transport, as well as cases in which licensees are 

22 transporting such material. Please note that the Subpart D requirements applicable to the 

23 transport of Category 1 quantities of radioactive material are more stringent than those 

24 applicable to Category 2 quantities. 

Applicants and licensees are required to implement the 10 CFR Part 37 security requirements 

before they take possession of an aggregated Category 1 or Category 2 quantity of 

radioactive material. 

Any licensee that has not previously been made subject to the provisions of 10 CFR Part 37, 

Subpart C shall notify the NRC regional office specified in 10 CFR 30.6 in writing at least 

90 days before aggregating radioactive material to a quantity that equals or exceeds the 

Category 2 threshold. Pursuant to 10 CFR 37.43(b), as part of the security program, the 

licensee must develop and maintain written procedures that document how the requirements 

of Subpart C will be met. These written procedures may be subject to NRC review 

and inspection.

25 For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

26 “Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

27 Category 2 Quantities of Radioactive Material.”” Additional information regarding best practices 

28 for protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

29 Security Best Practices for the Protection of Risk-Significant Radioactive Material.” 
8-60 

1 Response from Applicant: No response is required from an applicant or licensee. 

2 Compliance with access authorization and security program requirements may be reviewed 

3 during NRC inspections. 

4 8.11 Item 11: Waste Management 

5 Regulations: 10 CFR 20.2001(a), 10 CFR 20.2003, 10 CFR 20.2006, 10 CFR 20.2008, 

6 10 CFR 20.1904(b), 10 CFR 20.2108, 10 CFR 30.51, 10 CFR 37.11(c) 

7 Criteria: Radioactive waste must be disposed of in accordance with regulatory requirements 

8 and license conditions. Appropriate records of waste disposal must be maintained. 

9 Discussion: Radioactive waste is normally generated when conducting licensed activities. 

10 Such waste may include used or unused radioactive material, or unusable items contaminated 

11 with radioactive material (e.g., absorbent paper, gloves). Licensees may not receive radioactive 

12 waste from other licensees for processing, storage, or disposal, unless specifically authorized to 

13 do so by the NRC. Commercial radiopharmacies may request authorization to receive certain 

14 radioactive waste returned from their customers. For guidance on receiving radioactive waste 

15 from customers, refer to Section 8.11.1 titled, “Returned Wastes from Customers.” 

16 All radioactive waste must be stored in appropriate containers until its disposal, and the integrity 

17 of the waste containers must be assured. Radioactive waste containers must be appropriately 

18 labeled. All radioactive waste must be secured against unauthorized access or removal. The 

19 NRC requires commercial radiopharmacy licensees to manage radioactive waste generated at 

20 their facilities by one or more of the following methods: 

21  decay-in-storage (DIS) 

22  transfer to an authorized recipient 

23  release into sanitary sewerage 

24 Licensees may choose any one or more of these methods to dispose of their radioactive waste. 

25 It has been the NRC’s experience that most commercial radiopharmacies dispose of radioactive 

26 waste by DIS because the majority of licensed materials used by these facilities have short 

27 half-lives. 

28 An applicant’s programs for management and disposal of radioactive waste should include 

29 procedures for handling, safe and secure storage, characterization, minimization, and disposal 

30 of radioactive waste. Appropriate training should be provided to waste handlers. Regulations 

31 require that licensees maintain all appropriate records of disposal of radioactive waste. 

32 Note: Before licensed activities are transferred or assigned, in accordance with 

33 10 CFR 30.34(b), 10 CFR 40.46, and/or 10 CFR 70.36, if licensees are authorized to possess 

34 byproduct material with a half-life greater than 120 days in an unsealed form, source material in 

35 an unsealed form, and/or special nuclear material, the licensees must, in accordance with 

36 10 CFR 30.51(e), 10 CFR 40.61(e), and/or 10 CFR 70.51(b)(1)&(2), respectively, transfer the 

37 following records to the new licensee: 

38  records of disposal of licensed material made under: 

39 — 10 CFR 20.2002, “Method for obtaining approval of proposed 

40 disposal procedures“ 
8-61 

1 — 10 CFR 20.2003, “Disposal by release into sanitary sewerage” 

2 — 10 CFR 20.2004, “Treatment or disposal by incineration” 

3 — 10 CFR 20.2005, “Disposal of specific wastes” 

4  records required by 10 CFR 20.2103(b)(4) of the results of measurements and 

5 calculations used to evaluate the release of radioactive effluents to the environment 

6 Decay-in-Storage 

7 The NRC has concluded that materials with half-lives of less than or equal to 120 days are 

8 appropriate for DIS. The holding time of the waste should be based on the radionuclide(s), 

9 half-life, and the activity present when the waste was placed into storage. Such waste may be 

10 disposed of as ordinary trash if radiation surveys of the waste indicate that radiation levels are 

11 indistinguishable from background. The surveys should be performed with an appropriate 

12 radiation detection meter set on its most sensitive scale in a low background area and without 

13 any interposed shielding. In accordance with 10 CFR 20.1904(b), all radiation labels must be 

14 defaced or removed from containers and packages prior to disposal as ordinary trash, except 

15 for radiation labels on materials that are within containers and that will be managed as 

16 biomedical waste after they have been released. If the decayed waste is compacted, all labels 

17 that are visible in the compacted mass must also be defaced or removed. Applicants must 

18 maintain accurate records of such disposals. 

19 Transfer to an Authorized Recipient

20 Licensees may transfer radioactive waste to an authorized recipient for disposal. It has been 

21 NRC’s experience that most commercial radiopharmacies only dispose of radioactive wastes 

22 with half-lives greater than 120 days to authorized recipients (e.g., low-level radioactive waste 

23 disposal facilities). Because radiopharmacy licensees typically possess small quantities of 

24 these materials, the volume of materials disposed of in this manner would also be minimal, if 

25 any. Currently, radiopharmacies use this system for waste disposal infrequently; therefore, 

26 detailed guidance is not provided in this NUREG on the specific requirements related to the 

27 transfer of wastes to authorized recipients for disposal. 

Because of the difficulties and costs associated with disposal of sealed sources, applicants 

should preplan the disposal. Applicants may want to consider contractual arrangements with 

the source supplier as part of a purchase agreement. 

28 Release Into Sanitary Sewerage

29 Licensees may dispose of radioactive waste by release into sanitary sewerage if each of the 

30 following conditions are met: 

31  Material is readily soluble (or is easily dispersible biological material) in water. 

32  Quantity of licensed material that the licensee releases into the sewer each month 

33 averaged over the monthly volume of water released into the sewer does not exceed the 

34 concentration specified in 10 CFR Part 20, Appendix B, Table 3. 
8-62 

1  If more than one radionuclide is released, the sum of the ratios of the average monthly 

2 discharge of a radionuclide to the corresponding limit in 10 CFR Part 20, Appendix B, 

3 Table 3, cannot exceed unity. 

4  Total quantity of licensed material released into the sanitary sewerage system in a year 

5 does not exceed the limits specified in 10 CFR 20.2003(a)(4). 

6 Licensees are responsible for demonstrating that licensed materials discharged into the 

7 sewerage system are indeed readily dispersible in water. NRC IN 94-07, “Solubility Criteria for 

8 Liquid Effluent Releases to Sanitary Sewerage Under the Revised 10 CFR Part 20,” dated 

9 January 1994, provides the criteria for evaluating solubility of liquid waste. Careful consideration 

10 should be given to the possibility of re-concentration of radionuclides that are released into the 

11 sewer. The NRC alerted licensees to the potentially significant problem of re-concentration of 

12 radionuclides released to sanitary sewage systems in IN 84-94, “Re-concentration of 

13 Radionuclides Involving Discharges into Sanitary Sewage Systems Permitted under 

14 10 CFR 20.303 (now 10 CFR 20.2003),” dated December 1984. 

15 The regulations in 10 CFR 20.2003 are not applicable for releases to a private sewerage 

16 treatment system, a septic system, or leach fields. Licensees may make releases to these 

17 systems as effluents released to unrestricted areas subject to 10 CFR 20.1301, “Dose limits for 

18 individual members of the public.” However, if licensed material is released to a private sewage 

19 treatment system, septic system, or leach field, the sludge or other solids from these systems 

20 may become contaminated with radioactive material. Such sludge may be required to be 

21 disposed of as radioactive waste, using one of the methods described in this section. 

22  Applicants should provide procedures that will ensure that all releases of radioactive 

23 waste into a public sanitary sewerage, if any, meet the criteria stated in 10 CFR 20.2003, 

24 “Disposal by release into sanitary sewerage.” Licensees are required to maintain 

25 accurate records of all releases of licensed material into sanitary sewerage. 
8-63 

In accordance with 10 CFR 37.11(c), a licensee that possesses radioactive waste that contains 

Category 1 or Category 2 quantities of radioactive material as defined in 10 CFR 37.5 is 

exempt from the requirements of 10 CFR Part 37, Subparts B, C, and D. However, any 

radioactive waste that contains discrete sources, ion-exchange resins, or activated material 

that weighs less than 2,000 kg [4,409 lbs] is not exempt from the requirements of 

10 CFR Part 37. For additional guidance on implementing 10 CFR Part 37 requirements, see 

NUREG–2155, “Implementation Guidance for 10 CFR Part 37, “Physical Protection of 

Category 1 and Category 2 Quantities of Radioactive Material.”” Additional information 

regarding best practices for protection of risk-significant radioactive material is available in 

NUREG–2166, “Physical Security Best Practices for the Protection of Risk-Significant 

Radioactive Material.” 

A licensee possessing radioactive waste that is exempt under 10 CFR 37.11(c) from the 

requirements of 10 CFR Part 37, Subparts B, C, and D must implement the following 

requirements to secure the radioactive waste: 

 use continuous physical barriers that allow access to the radioactive waste only through 

established access control points; 

 use a locked door or gate with monitored alarm at the access control point; 

 assess and respond to each actual or attempted unauthorized access to determine 

whether an actual or attempted theft, sabotage, or diversion occurred; and 

 immediately notify the LLEA and request an armed response from the LLEA upon 

determination that there was an actual or attempted theft, sabotage, or diversion of 

the radioactive waste that contains Category 1 or Category 2 quantities of 

radioactive material.

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection.

1 Response from Applicant: Submit the following statement: “We have developed and will 

2 implement and maintain written procedures for waste management that meet the requirements 

3 in 10 CFR 20.1904(b), 10 CFR 20.2001(a), 10 CFR 20.2003, 10 CFR 20.2006, 

4 10 CFR 20.2108, 10 CFR 30.51, as applicable.” 

5 AND 

6 If the applicant wishes to compact and/or incinerate radioactive waste, then provide written 

7 procedures that will be implemented and maintained for compaction and/or incineration of 

8 radioactive waste. 

9 AND 

10 If access to a radioactive waste burial site is unavailable, the applicant should request 

11 authorization for extended interim storage of waste. The applicant should use the references 

12 listed below for guidance and submit the required information with the application. 

13 Note: DIS is authorized by a license condition. 
8-64 

1 References: 

2 Regulatory Issue Summary (RIS) 2011-09, “Available Resources Associated With Extended 

3 Storage Of Low-Level Radioactive Waste,” dated August 2011 

4 RIS 2004-17, Revision 1, “Revised Decay-in-Storage Provisions for the Storage of Radioactive 

5 Waste Containing Byproduct Material,” dated September 2005 

6 RIS 2016-11, “Requests to Dispose of Very Low-Level Radioactive Waste Pursuant to 

7 10 CFR 20.2002,” dated November 13, 2016 

8 Information Notice (IN) 94-23, “Guidance to Hazardous, Radioactive, and Mixed Waste 

9 Generators on the Elements of a Waste Minimization Program,” dated March 1994 

10 (ADAMS Accession No. ML9403160172) 

11 IN 94-07, “Solubility Criteria for Liquid Effluent Releases to Sanitary Sewerage Under the 

12 Revised 10 CFR Part 20,” dated January 1994 (ADAMS Accession No. ML9401240059) 

13 IN 84-94, “Reconcentration of Radionuclides Involving Discharges into Sanitary Sewage 

14 Systems Permitted Under 10 CFR 20.303” [now 10 CFR 20.2003], dated December 1984

15 8.11.1 Returned Wastes From Customers 

16 Regulations: 10 CFR 20.2001(a), 10 CFR 30.33, 10 CFR 71.5 

17 Criteria: Commercial radiopharmacies may receive radioactive waste from customers. This 

18 radioactive waste is limited to items that originated at the radiopharmacy and that contained 

19 (or contain) radioactive material delivered for customer use (e.g., pharmacy-supplied syringes 

20 and vials and their contents). 

21 Discussion: Commercial radiopharmacy licenses contain a license condition that permits 

22 radioactive waste, consisting of pharmacy-supplied items, to be received from their customers. 

23 The customer may return, and the radiopharmacy may accept for disposal, only items 

24 originating at the radiopharmacy that contained or contain radioactive material. This is limited to 

25 pharmacy-supplied syringes and vials and their contents. It is not acceptable for customers to 

26 return items originating at their facilities that are contaminated with radioactive material supplied 

27 by the pharmacy (e.g., gloves, absorbent material, and IV tubing) (see Figure 8-8). If an 

28 applicant wishes a broader authorization for radioactive waste retrieval, the applicant must apply 

29 for a separate license as a radioactive waste broker under the general provisions of 

30 10 CFR 20.2001(b) and 10 CFR 30.33, “General requirements for issuance of specific licenses.” 

31 The radiopharmacy should also have written instructions for pharmacy staff to address pick-up, 

32 receipt, and disposal of the returnable radioactive waste. Appendix P of this NUREG contains a 

33 model procedure for the return of pharmacy radioactive wastes from customers. 
8-65 

Figure 8-8. Returned Waste 

Only items that originated at the radiopharmacy (pharmacy-supplied syringes 

and vials and their contents) may be returned to the radiopharmacy for disposal. 

1 Response from Applicant: Submit the following statement: “We have developed and will 

2 implement and maintain written procedures for customer return of pharmacy-supplied syringes 

3 and vials and their contents, to specify that: 

4  Only pharmacy-supplied syringes and vials and their contents may be returned to 

5 the pharmacy. 

6  Instructions will be provided to radiopharmacy customers for the proper preparation and 

7 packaging of the radioactive waste for return to the radiopharmacy. 

8  Instructions will be provided to pharmacy staff for the pick-up, receipt, and disposal of 

9 the returned radioactive waste to ensure compliance with 10 CFR 20.2001(a), 

10 10 CFR 30.33, and 10 CFR 71.5, as applicable.” 

11 Note: Retrieval, receipt, and disposal of pharmacy-supplied syringes and vials from customers 

12 are authorized by a license condition. 

13 8.12 Item 12: License Fees 

14 On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and the amount of 

15 the fee enclosed with the application. 

16 Direct all questions about the NRC’s fees or the completion of Item 12 of NRC Form 313 to 

17 the Office of the Chief Financial Officer at NRC Headquarters in Rockville, Maryland, 

18 301-415-7554. Information about fees may also be obtained by calling the NRC’s toll-free 

19 number, 800-368-5642, extension 415-7554. The e-mail address for fees questions is 

20 Fees.Resource@nrc.gov. 

21 8.13 Item 13: Certification 

22 A representative of the corporation or legal entity filing the application should sign and date 

23 NRC Form 313. The representative signing the application must be authorized to make binding 

24 commitments and to sign official documents on behalf of the applicant. As discussed previously 

RPh04a.ppt

082898

Customer Returned Waste

Yes No
8-66 

1 in Chapter 3, “Management Responsibility,” signing the application acknowledges 

2 management’s commitment to and responsibility for the radiation protection program. The NRC 

3 will return all unsigned applications for proper signature.

4 Notes: 

5  It is a criminal offense to knowingly and willfully make a false statement or 

6 representation on applications or correspondence (18 U.S.C. 1001). 

7  When the application references commitments, those items will be incorporated into the 

8 license and, therefore, become binding regulatory requirements. 
9-1 

1 9 LICENSE AMENDMENTS AND RENEWALS 

2 It is the licensee’s obligation to keep the license current. If any of the information provided in 

3 the original application is to be modified or changed, the licensee must submit an application for 

4 a license amendment before the change takes place. The change is not in effect until the 

5 amendment has been issued. However, in accordance with Title 10 of the Code of Federal 

6 Register (10 CFR) 32.72(b)(5), commercial radiopharmacy licensees may allow individuals not 

7 named on their licenses to work as authorized nuclear pharmacists (ANPs), provided that the 

8 individuals meet the minimum training and experience requirements of 10 CFR 32.72(b)(2) 

9 or (4), and the licensee notifies the U.S. Nuclear Regulatory Commission (NRC), in writing, with 

10 the documentation specified in 10 CFR 32.72(b)(5), as applicable, no later than 30 days after 

11 the licensee allows the individual to work as an ANP. Also, to continue the license after its 

12 expiration date, the licensee must submit an application for a license renewal at least 30 days 

13 before the expiration date [10 CFR 2.109, 10 CFR 30.36(a)]. 

14 Applicants for license amendment or renewal should do the following: 

15  Use the most recent guidance in preparing an amendment or renewal request. 

16  Submit either an NRC Form 313 or a letter requesting amendment or renewal. 

17  Provide the license number and docket number. 

18  For renewals, provide a complete and up-to-date application including all required 

19 program elements outlined in Appendix B of this NUREG. Training documentation for 

20 personnel currently listed on the license does not need to be submitted as part of the 

21 renewal application. 

22 9.1 Timely Notification of Transfer of Control 

23 Regulation: 10 CFR 30.34(b) 

24 Criteria: Licensees must provide all supporting information and obtain the NRC’s prior, written 

25 consent, before transferring control of the license, also referred to as a “change of ownership” 

26 and/or “transferring the license.” 

27 Discussion: Transferring control may be the result of mergers, buyouts, or majority stock 

28 transfers. Although it is not the NRC’s intent to interfere with the business decisions of 

29 licensees, under 10 CFR 30.34(b) and the Atomic Energy Act, licensees must obtain prior NRC 

30 written consent before transferring control of the license to ensure the following: 

31  Radioactive materials are possessed, used, or controlled only by persons who have 

32 valid NRC licenses or Agreement State licenses. 

33  Materials are properly handled and secured. 

34  Persons using these materials are capable, competent, and committed to implementing 

35 appropriate radiological controls. 

36  A clear chain of custody is established to identify who is responsible for disposition of 

37 records and licensed material. 
9-2 

1  Public health and safety are not compromised by the use of such materials. 

2  Adequate financial assurance is provided for compliance with the applicable NRC 

3 requirements, if required. 

4 Response from Applicant: No response is required from an applicant for a new license. 

5 However, current licensees should refer to NUREG–1556, Volume 15, “Consolidated Guidance 

6 About Materials Licenses: Guidance About Changes of Control and About Bankruptcy Involving 

7 Byproduct, Source, or Special Nuclear Materials Licenses,” for more information about transfer 

8 of control (i.e., ownership). 

9 Reference: For further information, see RIS 2014-08, Revision 1, “Regulatory Requirements for 

10 Transfer of Control (Change of Ownership) of Specific Materials Licenses,” dated May 5, 2016. 

11 This RIS can be found on the NRC’s Generic Communications Web page under “Regulatory 

12 Issue Summaries:” at http://www.nrc.gov/reading-rm/doc-collections/gen-comm/. 
10-1 

1 10 APPLICATIONS FOR EXEMPTIONS 

2 Regulations: 10 CFR 19.31, 10 CFR 20.2301, 10 CFR 30.11 

3 Criteria: Licensees may request exemptions from U.S. Nuclear Regulatory Commission (NRC) 

4 regulations. The licensee must demonstrate that the exemption is authorized by law; will not 

5 endanger life, property, or the common defense and security; and is otherwise in the public 

6 interest. Licensees may also use existing specific exemptions outlined in the Title 10 of the 

7 Code of Federal Register (10 CFR) regulations if they meet the established criteria. 

8 Discussion: Various sections of the NRC’s regulations address requests for exemptions 

9 (e.g., 10 CFR 19.31, “Application for exemptions;” 10 CFR 20.2301, “Applications for 

10 exemptions;” 10 CFR 30.11, “Specific exemptions”). These regulations state that the NRC may 

11 grant an exemption, acting on its own initiative or on an application from an interested person. 

12 Exemptions are not intended to revise regulations or apply to large classes of licensees and are 

13 generally limited to unique situations. Requests for exemptions submitted to the NRC must 

14 identify the regulation for which the exemption is being requested and include a justification for 

15 the requested exemption. 

Unless the NRC has granted an exemption, in writing, licensees must comply with all 

applicable regulations. 

11-1 

1 11 TERMINATION OF ACTIVITIES 

2 Regulations: 10 CFR 20.1401, 10 CFR 20.1402, 10 CFR 20.1403, 10 CFR 20.1404, 

3 10 CFR 20.1405, 10 CFR 20.1406, 10 CFR 30.34(b), 10 CFR 30.35(g), 10 CFR 30.36, 

4 10 CFR 30.36(d), 10 CFR 30.36(g), 10 CFR 30.36(h), 10 CFR 30.36(j), 10 CFR 30.51(f), 

5 10 CFR 40.36(f), 10 CFR 40.42, 10 CFR 40.42(d), 10 CFR 40.42(g), 10 CFR 40.42(h), 

6 10 CFR 40.42(j), 10 CFR 40.46, 10 CFR 70.36, 10 CFR 70.38, 10 CFR 70.38(d), 

7 10 CFR 70.38(g), 10 CFR 70.38(h), 10 CFR 70.38(j), 10 CFR 70.51(b)(3) 

8 Criteria: The licensee must do the following: 

9  Notify the U.S. Nuclear Regulatory Commission (NRC), in writing, within 60 days of the 

10 occurrence of any of the following: 

11 — expiration of its license 

— a decision to permanently cease principal activities1 12 at the entire site 

13 — for licensees subject to Title 10 of the Code of Federal Register (10 CFR) 30.36, 

a decision to permanently cease principal activities1 14 in any separate building or 

15 outdoor area that contains residual radioactivity such that the building or area is 

16 unsuitable for release according to NRC requirements 

17 — for licensees subject to 10 CFR 40.42 or 10 CFR 70.38, a decision to 

permanently cease principal activities1 18 in any separate building or outdoor area 

— no principal activities1 19 under the license have been conducted for a period of 

20 24 months 

— no principal activities1 21 have been conducted for a period of 24 months in any 

22 separate building or outdoor area that contains residual radioactivity such 

23 that the building or outdoor area is unsuitable for release according to 

24 NRC requirements 

25  Submit a decommissioning plan, if required by 10 CFR 30.36(g), 10 CFR 40.42(g), 

26 and/or 10 CFR 70.38(g). 

27  Conduct decommissioning, as required by 10 CFR 30.36(h) and (j), 10 CFR 40.42(h) 

28 and (j), and/or 10 CFR 70.38(h) and (j). 

29  Submit to the appropriate NRC regional office a completed NRC Form 314, “Certificate 

30 of Disposition of Materials” (or equivalent information), and information demonstrating 

31 that the premises are suitable for release for unrestricted use (e.g., results of final 

32 surveys and results of leak tests of sealed sources). 

 

1

Principal activities are activities which are essential to achieving the purpose(s) for which the license was issued or 

amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to 

decontamination or decommissioning are not principal activities.
11-2 

1  Before a license is terminated, send records important to decommissioning that are 

2 required by 10 CFR 30.35(g), 10 CFR 40.36(f), and/or 10 CFR 70.25(g) to the 

3 appropriate NRC regional office in accordance with 10 CFR 30.51(f), 10 CFR 40.61(f), 

4 and/or 10 CFR 70.51(a)(3), respectively. If licensed activities are transferred or 

5 assigned in accordance with 10 CFR 30.34(b), 10 CFR 40.46, and/or 10 CFR 70.36, 

6 transfer records important to decommissioning to the new licensee in accordance with 

7 10 CFR 30.35(g), 10 CFR 40.36(f), and/or 10 CFR 70.51(b)(3), respectively. 

8  Before a license is terminated, send records of disposal of licensed material made under 

9 10 CFR 20.2002, 10 CFR 20.2003-20.2005, and the results of measurements and 

10 calculations used to evaluate the release of radioactive effluents to the environment 

11 to the appropriate NRC regional office in accordance with 10 CFR 30.51(d), 

12 10 CFR 40.61(d), and/or 10 CFR 70.51(a)(1) and (2), if authorized to possess byproduct 

13 material with a half-life greater than 120 days in an unsealed form, source material in an 

14 unsealed form, and/or special nuclear material, respectively. 

15 Discussion: To comply with the above criteria, before a licensee can decide whether it must 

16 notify the NRC under 10 CFR 30.36(d), 10 CFR 40.42(d), and/or 10 CFR 70.38(d), the licensee 

17 must determine whether residual radioactivity is present and, if so, whether the levels make the 

18 building or outdoor area unsuitable for release, according to NRC requirements. A licensee’s 

19 determination that a facility is not contaminated is subject to verification by NRC inspection. 

The permanent cessation of principal activities1 20 in an individual room or laboratory may require 

21 the licensee to notify the NRC if no other licensed activities are being performed in the building. 

22 This requirement also applies to buildings that were approved by the broad scope licensee as 

23 locations of use but not specifically named on the broad scope license. 

24 For information about requirements that apply to the timeliness of decommissioning, see 

25 Regulatory Issue Summary (RIS) 2015-19, Revision 1, “Decommissioning Timeliness Rule 

26 Implementation and Associated Regulatory Relief,” dated September 27, 2016, which can be 

27 found on the NRC’s Generic Communications Web page under “Regulatory Issue Summaries”: 

28 http://www.nrc.gov/reading-rm/doc-collections/gen-comm/reg-issues/2015/. 

29 For guidance on the disposition of licensed material, see Section 8.11 “Waste Management.” 

30 For guidance on decommissioning records, see Section 8.5.2, “Financial Assurance and 

31 Recordkeeping for Decommissioning.” 

32 NUREG–1757, “Consolidated Decommissioning Guidance,” contains the current regulatory 

33 guidance concerning decommissioning of facilities and termination of licenses. Licensees that 

34 have large facilities to decommission should review NUREG–1575, “Multi-Agency Radiation 

35 Survey and Site Investigation Manual (MARSSIM).” The computer code “DandD” offers an 

36 acceptable method for calculating screening values to demonstrate compliance with the 

37 unrestricted dose limits. Supplemental information on the implementation of the final rule on 

38 radiological criteria for license termination was published in the Federal Register (63 FR 64132) 

39 on November 18, 1998. 

40  Supplemental information on the implementation of the final rule on radiological criteria 

41 for license termination also was published in the Federal Register (FR) on 

42 December 7, 1999, (64 FR 68395), which addresses screening values in soils for the 

43 most common radionuclides, and in the FR on June 13, 2000, (65 FR 37186) for 
11-3 

1 screening values for building surfaces and soils contaminated with radionuclides not 

2 addressed in the prior FR notices. 

3 Response from Applicant: The applicant is not required to submit a response to the NRC 

4 during the initial application. The licensee’s obligations in this matter begin when the license 

5 expires or at the time the licensee ceases operations, whichever is earlier. These obligations 

6 are to undertake the necessary decommissioning activities, to submit NRC Form 314 or 

7 equivalent information, and to perform any other actions summarized in “Criteria” above.

8 Reference: 

9 NRC Form 314 is available at http://www.nrc.gov/reading-rm/doc-collections/forms. 

1 APPENDIX A 

2 UNITED STATES NUCLEAR REGULATORY COMMISSION FORM 313

A–1 

1 U.S. Nuclear Regulatory Commission Form 313 

2 Please use the most current version of this form, which may be found at: 

3 http://www.nrc.gov/reading-rm/doc-collections/forms/

4 

1 APPENDIX B 

2 SUGGESTED FORMAT FOR PROVIDING INFORMATION REQUESTED IN 

3 ITEMS 5 THROUGH 11 OF NRC FORM 313

B–1 

1 Suggested Format for Providing Information Requested in Items 5 

2 Through 11 on NRC Form 313 

Item 

No. Title and Criteria Yes

Description 

Attached

5. RADIOACTIVE MATERIAL 

Sealed And/Or Unsealed Byproduct Material

 

 For unsealed materials: 

 Identify each radionuclide (element name and mass number) 

that will be used, the form, and the maximum requested 

possession limit. 

❒

AND 

 For potentially volatile materials (e.g., iodine-123, 

iodine-131), specify whether the materials will be 

manipulated at the radiopharmacy. 

❒ N/A 

 For sealed sources and discrete sources of radium-226: 

 Identify each radionuclide (element name and mass number) 

that will be used in each source, the activity per source, and 

the maximum requested possession limit. 

❒

 Provide the manufacturer’s (distributor’s) name and model 

number for each sealed source and device and discrete 

source of radium-226 requested. 

❒

 We confirm that each sealed source, device, source/device 

combination, and discrete source of radium-226 is registered 

as an approved sealed source, device, or discrete source by 

the U.S. Nuclear Regulatory Commission (NRC) or by an 

Agreement State. 

❒ N/A 

 We confirm that the activity per source and its maximum 

activity will not exceed the maximum activity listed on the 

approved certificate of registration issued by the NRC or by 

an Agreement State. 

❒ N/A 

 If the above information cannot be provided for the discrete 

source of radium-226, describe the discrete source and its 

physical boundaries. 

❒

 For depleted uranium (DU), specify the total amount (in kg). ❒

Financial Assurance and Recordkeeping for 

Decommissioning

 If financial assurance is required, submit documentation 

required by Title 10 of the Code of Federal Regulations

10 CFR 30.35.

❒
B–2 

Item 

No. Title and Criteria Yes

Description 

Attached

6. PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL 

BE USED

 For all transferred, distributed, and redistributed sealed and 

unsealed materials:

 Provide a statement that, “We have developed and will 

implement and maintain written procedures to ensure 

compliance with the license verification requirements 

specified in 10 CFR 30.41(d).” 

 ❒

AND

 Describe procedures to ensure that sealed and unsealed 

materials are securely and safely provided to mobile medical 

licensees if they are transferred, distributed, or redistributed 

to a mobile medical licensee’s mobile van or coach, and 

there is no permanent structure for byproduct material 

storage. For example, procedures should ensure that 

delivery directly to the van will only occur if the van is 

occupied by mobile medical licensee personnel at the time 

of delivery. 

 ❒

AND

 Provide the following, as applicable: 

For radiopharmaceuticals: 

 Confirm that radiopharmaceuticals will be prepared under 

the supervision of an Authorized Nuclear Pharmacist (ANP) 

or will be obtained from a supplier authorized pursuant to 10 

CFR 32.72, or under equivalent Agreement State 

requirements. 

❒

 Describe all licensed material to be distributed or 

redistributed. 

❒

 For generators: 

 Confirm that the generators will be obtained from a 

manufacturer licensed pursuant to 10 CFR 32.72, or under 

equivalent Agreement State requirements. 

❒

 Confirm that unused generators will be redistributed without 

opening or altering the manufacturer’s packaging. 

❒

 For redistribution of used generators: 

 Describe the procedures and instructions for safely 

repackaging the generators, including the use of the 

manufacturer’s original packaging and minimization of 

migration of radioactive fluids out of the generator 

during transport. 

 ❒
B–3 

Item 

No. Title and Criteria Yes

Description 

Attached

6. PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE 

USED (Continued)

 

 Confirm that the manufacturer’s packaging and labeling will 

not be altered. 

❒ 

 Confirm that the generator will not be distributed beyond the 

expiration date shown on the generator label. 

❒

 Confirm that the redistributed generator will be accompanied 

by the manufacturer-supplied leaflet or brochure that 

provides radiation safety instructions for handling and using 

the generator. 

❒

 Confirm that only generators used in accordance with the 

manufacturer’s instructions will be redistributed. 

❒ 

 For Redistribution of Sealed Sources for Brachytherapy 

or Diagnosis: 

 

 Confirm that the sealed sources for brachytherapy or 

diagnosis to be redistributed will be obtained from a 

manufacturer authorized to distribute sealed sources for 

brachytherapy or diagnosis in accordance with a specific 

license issued pursuant to 10 CFR 32.74 or under equivalent 

Agreement State requirements. 

❒

 Confirm that the manufacturer’s packaging, labeling, and 

shielding will not be altered and that redistributed sources 

will be accompanied by the manufacturer-supplied package 

insert, leaflet, brochure, or other document that provides 

radiation safety instructions for handling and storing 

the sources. 

❒ 

 For Redistribution of Calibration and Reference 

Sealed Sources: 

 

 Confirm that calibration and reference sealed sources to be 

redistributed to medical use licensees will be obtained from 

a person licensed pursuant to 10 CFR 32.74 to initially 

distribute such sources. 

❒

 Confirm that the manufacturer’s labeling and packaging will 

not be altered and that redistributed sources will be 

accompanied by the manufacturer-supplied calibration 

certificate and the leaflet, brochure, or other document that 

provides radiation safety instructions for handling and 

storing the sources. 

❒ 

 
B–4 

Item 

No. Title and Criteria Yes

Description 

Attached

6. PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE 

USED (Continued)

 For Redistribution of Prepackaged Units for In Vitro Tests: 

 Confirm that the prepackaged units for in vitro tests to be 

redistributed will be obtained from a manufacturer 

authorized to distribute the prepackaged units for in vitro

tests in accordance with a specific license issued pursuant 

to 10 CFR 32.71 or under an equivalent license of an 

Agreement State. 

❒ 

 For Redistribution of Prepackaged Units for In Vitro Tests to 

General Licensees: 

 Confirm that the manufacturer’s packaging and labeling of 

the prepackaged units for in vitro tests will not be altered in 

any way. 

❒ 

 Confirm that each redistributed prepackaged unit for in vitro

tests will be accompanied by the manufacturer-supplied 

package insert, leaflet, or brochure that provides radiation 

safety instructions for general licensees. 

❒ 

 For Redistribution of Prepackaged Units for In Vitro Tests to 

Specific Licensees: 

 Confirm that the labels, package insert, leaflet, brochure, or 

other documents accompanying the redistributed 

prepackaged units for in vitro tests will NOT reference 

general licenses, exempt quantities, or NRC’s regulations 

that authorize a general license (e.g., 10 CFR 31.11). 

❒ 

 Confirm that the labeling on redistributed prepackaged units 

for in vitro tests will conform to the requirements of 

10 CFR 20.1901, “Caution signs” and 20.1904, “Labeling 

containers.” 

❒ 

 For Redistribution of Discrete Sources of radium-226: 

 Confirm that the discrete sources of radium-226 will be 

obtained by a manufacturer authorized to distribute it. 

❒ 

 Confirm that the manufacturer’s packaging, labeling, and 

shielding will not be altered and that redistributed sources 

will be accompanied by the manufacture-supplied package 

insert, leaflet, brochure, or other document that provides 

radiation safety instructions for handling and storing 

sources. 

❒ 

 
B–5 

Item 

No. Title and Criteria Yes

Description 

Attached

6. PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL 

BE USED (Continued)

 For radiopharmaceutical preparation, we will perform: 

 compounding of iodine-131 capsules ❒

 radioiodination ❒ 

 chemical synthesis of Positron Emission Tomography (PET) 

radiopharmaceuticals 

❒ 

 technetium-99m kit preparation ❒ 

 other, specify ❒ ❒

 Supply specific information concerning the use of discrete 

sources of radium-226, sealed sources for reference and 

calibration, and DU shielding. 

❒

 We will provide customers the following radiation protection 

services involving licensed material: 

 

 leak testing ❒

 instrument calibration ❒ 

 other, specify ❒ ❒

7. INDIVIDUAL(S) RESPONSIBLE FOR RADIATION 

SAFETY PROGRAM AND THEIR TRAINING AND 

EXPERIENCE

 

 For applicant’s management structure, provide: 

 An organizational chart describing the management 

structure, reporting paths, and the flow of authority between 

executive management and the Radiation Safety Officer 

(RSO). 

 ❒ 

For the RSO, provide: 

 Name of the proposed RSO. ❒ 

AND 

 A copy of the license (NRC or Agreement State) that 

authorized the uses requested and on which the individual 

was specifically named as the RSO, ANP, or AU.

 ❒ 

OR 

 Description of the training and experience demonstrating that 

the proposed RSO is qualified by training and experience 

applicable to commercial nuclear pharmacies. 

 ❒ 
B–6 

Item 

No. Title and Criteria Yes

Description 

Attached

7. INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY 

PROGRAM AND THEIR TRAINING AND EXPERIENCE 

(Continued)

 

Note: See Appendix D of this NUREG for formats to use for 

documenting hours of training in techniques and hours of 

experience using radionuclides. 

 

For each proposed ANP, provide the following: 

 Name of the proposed ANP ❒

AND 

 Pharmacist’s license number and issuing entity. ❒

AND 

For an individual previously identified as an ANP on an NRC or 

Agreement State license or permit or by a commercial nuclear 

pharmacy that has been authorized to identify ANPs 

[10 CFR 32.72(b)(2)(i)]:

 

 Previous license number (if issued by NRC) or a copy of the 

license (if issued by an Agreement State), or a copy of a permit 

issued by an NRC master materials licensee, a permit issued by 

an NRC or Agreement State broad scope licensee, or a permit 

issued by an NRC Master Materials License broad scope 

permittee on which the individual was named an ANP, or a copy 

of an authorization as an ANP from a commercial nuclear 

pharmacy that has been authorized to identify ANPs.

❒

OR

For an individual qualifying under 10 CFR 32.72(b)(4):

 Documentation that the individual was a nuclear pharmacist 

preparing only radioactive drugs containing acceleratorproduced radioactive material.

❒ 

AND

 Documentation that the individual practiced at a pharmacy, a 

Government agency or federally recognized Indian Tribe 

before November 30, 2007, or at all other pharmacies before 

August 8, 2009, or an earlier date as noticed by the NRC.

❒ 

OR

For an individual qualifying under 10 CFR 35.55(a):

 Copy of the certification(s) by the specialty board whose 

certification process has been recognized under 

10 CFR 35.55(a).

❒ 

AND
B–7 

Item 

No. Title and Criteria Yes

Description 

Attached

7. INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY 

PROGRAM AND THEIR TRAINING AND EXPERIENCE 

(Continued) 

Written attestation, signed by a preceptor ANP, that training and 

experience required for certification have been satisfactorily 

completed and that a level of competency sufficient to function 

independently as an ANP has been achieved.

❒

AND

 If applicable, a description of recent related continuing education 

and experience, as required by 10 CFR 35.59. 

❒ 

OR

For an individual qualifying under 10 CFR 32.72(b)(2)(ii):

 Description of the training and experience specified in 

10 CFR 35.55(b), demonstrating that the proposed ANP is 

qualified by training and experience.

❒ 

AND

 Written attestation, signed by a preceptor ANP, that training and 

experience required for certification have been satisfactorily 

completed and that a level of competency sufficient to function 

independently as an ANP has been achieved.

❒ 

AND

 If applicable, a description of recent related continuing education 

and experience as required by 10 CFR 35.59.

❒ 

Notes: 

 NRC Form 313A (ANP), “Authorized Nuclear Pharmacist 

Training and Experience and Preceptor Attestation 

[10 CFR 35.55]” may be used to document training and 

experience for those individuals qualifying under 

10 CFR 35.55(a) or (b). 

 Descriptions of training and experience will be reviewed 

using the criteria listed above. The NRC will review the 

documentation to determine if the applicable criteria in 

10 CFR 32.72(b)(2) are met. If the training and experience 

do not appear to meet the criteria, the NRC may request 

additional information from the applicant or may request 

the assistance of the Advisory Committee on the Medical 

Uses of Isotopes (ACMUI) in evaluating such training 

and experience.
B–8 

Item 

No. Title and Criteria Yes

Description 

Attached

7. INDIVIDUAL(S) RESPONSIBLE FOR RADIATION 

SAFETY PROGRAM AND THEIR TRAINING AND 

EXPERIENCE (Continued) 

 

For each proposed Authorized User (AU), provide the 

following: 

 Name of each proposed AU ❒ 

AND

 Types, quantities, and proposed uses of licensed material. ❒ 

AND

 A copy of the license (NRC or Agreement State) on which 

the individual was specifically named as an AU for the types, 

quantities, and proposed uses of licensed materials.

❒ 

OR

 A copy of the permit maintained by a licensee of broad scope 

that identifies the individual as an AU for the types, 

quantities, and proposed uses of licensed materials.

OR 

❒ 

 A description of the training and experience demonstrating 

that the proposed AU is qualified by training and experience 

to use the requested licensed materials. The applicant may 

find it convenient to describe this training and experience 

using a format similar to Table D–1 in Appendix D of this 

NUREG. 

❒ 

Occupationally Exposed Workers and Ancillary Personnel

 “We have developed and will implement and maintain written 

procedures for a training program for each group of workers, 

including (i) topics covered, (ii) qualifications of the instructors, 

(iii) method of training, (iv) method for assessing the success of 

the training, (v) initial training, and (vi) annual refresher training.”

❒

Personnel Involved in Hazardous Materials Package 

Preparation and Transport

 

 “We have developed and will implement and maintain written 

procedures for training personnel involved in hazardous 

materials package preparation and transport that meet the 

requirements in 49 CFR 172.700, 49 CFR 172.702, and 

49 CFR 172.704, as applicable.”

❒ 

 
B–9 

Item 

No. Title and Criteria Yes

Description 

Attached

8. TRAINING FOR INDIVIDUALS WORKING IN OR 

FREQUENTING RESTRICTED AREAS (INSTRUCTIONS TO 

OCCUPATIONALLY EXPOSED WORKERS AND ANCILLARY 

PERSONNEL)

 Instruction for Supervised Individuals Preparing 

Radiopharmaceuticals 

Need Not Be 

Submitted with 

Application

9. FACILITIES AND EQUIPMENT 

Provide a copy of the registration or license from a State Board 

of Pharmacy as a pharmacy, or provide evidence that the facility 

is operating as a nuclear pharmacy within a Federal medical 

institution.

❒ ❒ 

 AND 

Describe the facilities and equipment to be made available at 

each location where radioactive material will be used. A 

diagram should be submitted that shows the applicant’s entire 

facility and identifies activities conducted in all contiguous areas 

surrounding the facility. Diagrams should be drawn to a 

specified scale, or dimensions that are indicated.

 ❒ 

 AND 

The diagram(s) should also include: 

1. Descriptions of the area(s) assigned for the production or 

receipt, storage, preparation, measurement, and distribution 

of radioactive materials and the location(s) for radioactive 

waste storage. 

 ❒ 

2. Sufficient detail in the diagram to indicate locations of 

shielding, the proximity of radiation sources to unrestricted 

areas, and other items related to radiation safety. 

 ❒ 

3. A general description of the ventilation system, including 

representative equipment such as gloveboxes or fume 

hoods. (Note: Pertinent airflow rates, differential pressures, 

filtration equipment, and monitoring systems should be 

described in terms of the minimum performance to be 

achieved.) 

 ❒ 

4. Confirmation that such systems will be employed for the use 

or storage of radioactive materials likely to become airborne, 

such as for compounding radioiodine capsules and 

dispensing radioiodine solutions. 

 ❒ 

 
B–10 

Item 

No. Title and Criteria Yes

Description 

Attached

9. FACILITIES AND EQUIPMENT (Continued)

5. Verification that ventilation systems ensure that effluents are 

as low as is reasonably achievable, are within the dose limits 

of 10 CFR 20.1301, and are within the constraint on air 

emissions established under 10 CFR 20.1101(d). 

❒

6. Mark drawings, diagrams, and descriptions that provide the 

exact location of materials or depict specific locations of 

security equipment as, “Security-Related Information—

Withhold under 10 CFR 2.390.” 

❒

 For PET Radiopharmacies

Provide a copy of the registration or license from a State Board 

of Pharmacy, or provide evidence that the facility is operating as 

a nuclear pharmacy within a Federal medical institution. 

❒ 

 AND

Describe the facilities and equipment to be made available at 

each location where radioactive material will be used, including 

the method and shielding used to physically transfer licensed 

material (e.g., transfer lines) to the different processes 

(e.g., chemical synthesis, dispensing).

❒ 

 AND

Provide a diagram that shows the entire facility and identifies 

activities conducted in all contiguous areas surrounding the 

facility. Diagrams should be drawn to a specified scale, or 

dimensions should be indicated. Include the following 

information:

❒ 

 Descriptions of the area(s) assigned for the production or 

receipt, storage, preparation, measurement, and distribution 

of radioactive materials and the location(s) for radioactive 

waste storage. 

❒ 

 Sufficient detail in the diagram to indicate locations of 

shielding and/or shielding equipment (e.g., hot cells for 

positron-emitting radionuclides), the proximity of radiation 

sources to unrestricted areas, and other items related to 

radiation safety, such as remote handling equipment and area 

monitors. 

❒ 

 A general description of the ventilation system, including 

representative equipment such as glove boxes or fume hoods. 

Pertinent airflow rates, differential pressures, filtration 

equipment, and monitoring systems should be described in 

terms of the minimum performance to be achieved. Confirm 

that such systems will be employed for the production, use, or 

storage of radioactive materials. 

❒ 

 
B–11 

Item 

No. Title and Criteria Yes

Description 

Attached

9. FACILITIES AND EQUIPMENT (Continued)

 Verification that ventilation systems ensure that effluents are 

ALARA, are within the dose limits of 10 CFR 20.1301, and 

are within the ALARA constraints for air emissions 

established under 10 CFR 20.1101(d). 

❒ 

10. RADIATION SAFETY PROGRAM

 Audit and Review of Program 

The applicant’s program for reviewing the content and 

implementation of its Radiation Protection Program will be 

examined during inspections, but it should not be submitted in 

the license application.

Need Not be 

Submitted with 

Application

 Radiation Monitoring Instruments 

Provide the following: 

 A statement that, “We will use calibrated and operable 

equipment that is capable of detecting the type(s) of 

radiation being monitored and energy or energy range of the 

radiation being measured.” 

❒

 OR 

 Describe the calibrated and operable instrumentation that 

will be used to perform radiation monitoring (e.g., portable or 

stationary count rate meters, LSCs, well-type scintillation 

counters, air monitors). 

 ❒

 AND 

 A statement that, “We reserve the right to upgrade our 

monitoring instrumentation as necessary as long as the 

instruments are adequate to measure the type and level of 

radiation for which they are used.”

❒ 

 AND 

 If calibration is performed by a person or firm outside the 

applicant’s organization, specify that the calibration will be 

performed by an NRC or Agreement State licensee 

specifically authorized to perform instrument calibration as a 

service to other licensees.

 ❒ 

 OR 
B–12 

Item 

No. Title and Criteria Yes 

Description 

Attached 

10. RADIATION SAFETY PROGRAM (Continued)

 If the calibration is to be performed in-house, submit the 

instrument calibration procedure that will be used. 

Instrument calibration guidelines are included in Appendix 

G of this NUREG, and they may be used to assist with 

development of the instrument calibration procedure. In 

addition, identify the qualifications of the individuals who will 

perform the calibrations.

 ❒ 

Material Receipt and Accountability 

 Provide the following statements: 

 “We will develop, implement, and maintain written 

procedures for safely opening packages that meet the 

requirements in 10 CFR 20.1906. 

❒ 

AND 

 “We will conduct physical inventories of sealed sources of 

licensed material at intervals not to exceed 6 months.” 

❒ 

AND 

 “We will develop, implement, and maintain written 

procedures for licensed material accountability and control 

to ensure that: 

❒

— License possession limits are not exceeded. 

— Licensed material in storage is secured from 

unauthorized access or removal. 

— Licensed material not in storage is maintained under 

constant surveillance and control. 

— Records of receipt (either from the licensee’s own 

production operations or from another licensee), 

transfer, and disposal of licensed material are 

maintained. 

❒

❒

❒

❒ 

AND 

 If applicable, “We will comply with the National Source 

Tracking System (NSTS) reporting requirement as 

described in 10 CFR 20.2207, ‘Reports of Transactions 

Involving Nationally Tracked Sources.’” 

❒

 
B–13 

Item 

No. Title and Criteria Yes

Description 

Attached

10. RADIATION SAFETY PROGRAM (Continued) 

Occupational Dosimetry

 Provide one of the following statements: 

 “We will maintain, for inspection by the NRC, documentation 

demonstrating that unmonitored individuals are not likely to 

receive a radiation dose in excess of the limits in 

10 CFR 20.1502.” 

❒

OR 

 “We will monitor individuals in accordance with the criteria in 

the section titled, ‘Radiation Safety Program–Occupational 

Dose’ in NUREG–1556, Vol. 13, Rev. 2, “Consolidated 

Guidance About Materials Licenses: Program-Specific 

Guidance About Commercial Radiopharmacy Licenses.”

❒

OR, IN LIEU OF THESE STATEMENTS

 Provide a description of an alternative method for demonstrating 

compliance with the referenced regulations. 

❒ 

Public Dose 

 The applicant’s program to control doses received by individual 

members of the public will be examined during inspection, but it 

should not be submitted in a license application.

Need Not Be 

Submitted with 

Application

Safe Use of Radionuclides and Emergency Procedures 

 Submit the following statements: 

 “We have developed and will implement and maintain written 

procedures for the safe use of radioactive materials that 

address

❒

 — facility and personnel radioactive contamination 

minimization, detection, and control 

— performing molybdenum-99 breakthrough 

measurements of each eluate of a 

molybdenum-99/technetium-99m generator 

— use of protective clothing and equipment by 

personnel that meet the requirements in 10 CFR 

20.1101, 10 CFR 20.1801, 10 CFR 20.1802, 10 

CFR 30.34(g), and 10 CFR 19.11(a)(3), as 

applicable.” 

 
B–14 

Item 

No. Title and Criteria Yes

Description 

Attached

10. RADIATION SAFETY PROGRAM (Continued)

AND

 “We have developed and will implement and maintain written 

procedures for identifying and responding to emergencies 

involving radioactive material, including” 

❒ 

 — lost, stolen, or missing licensed material 

— exposures to personnel and the public in excess 

of NRC regulatory limits 

— releases of licensed materials in effluents and the 

sanitary sewer in excess of NRC regulatory limits

— excessive radiation levels or radioactive material 

concentrations in restricted or unrestricted areas 

— radioactive spills and contamination 

— fires, explosions, and other disasters with the 

potential for the loss of containment of licensed 

material 

— routine contacts with local fire departments and 

Local Law Enforcement Agencies (LLEAs) that 

meet the requirements in 10 CFR 

20.1101,10 CFR 20.2201-2203, and 10 CFR 

30.50 and other requirements, as applicable. 

Surveys 

Submit the following statement: 

 “We have developed and will implement and maintain written 

procedures for a survey program that includes: 

(1) performance of radiation and contamination level surveys in 

restricted and unrestricted areas, (2) personnel contamination 

monitoring, (3) action levels, (4) survey frequencies, and 

(5) maintenance of survey records that meet the requirements 

in 10 CFR 30.53, 10 CFR 20.1501, and 10 CFR 20.2103, 

as applicable.”

❒ 

 
B–15 

Item 

No. Title and Criteria Yes

Description 

Attached

10. RADIATION SAFETY PROGRAM (Continued) 

Dosage Measurement Systems 

 Describe the types of systems (measurement or combination of 

measurement and calculation) to be used for the measurement 

of alpha-, beta-, gamma-, and photon-emitting radioactive drugs.

❒

AND 

For each dose measurement system used to measure the 

amount of radioactivity in alpha-, beta-, gamma-, and 

photon-emitting radioactive drugs, state: “We have developed 

and will implement and maintain a written procedure for the 

performance of dosage measurement system checks and tests 

that meets the requirement in 10 CFR 32.72(c).” 

❒

AND

If applicable, include a sample calculation for determining 

beta-correction factors for dose calibrators with 

ionization chambers.

 ❒

OR 

If applicable, include a means for ensuring the accuracy of 

beta-correction factors supplied by the instrument manufacturer 

or other entity.

 ❒ 

Transportation

The applicant’s program for transportation will be examined 

during inspection but should not be submitted in a 

license application. 

Need Not Be 

Submitted with 

Application

Minimization of Contamination 

The applicant does not need to provide a response to this item 

under the following condition: NRC will consider that the criteria 

have been met if the applicant’s responses meet the criteria for 

the following sections of NUREG-1556, Volume 13, Rev. 2: 

Section 8.9, “Facilities and Equipment;” Section 8.10.6, “Safe 

Use of Radionuclides and Emergency Procedures;” 

Section 8.10.7, “Surveys;” Section 8.10.13, “Leak Tests;” and 

Section 8.11, “Item 11: Waste Management.”

 

 
B–16 

Item 

No. Title and Criteria Yes 

Description 

Attached 

10. RADIATION SAFETY PROGRAM (Continued) 

Radioactive Drug Labeling for Distribution 

Describe all labels, indicating the colors to be used, that will 

accompany the products and describe where each label is 

placed (e.g., on the “transport radiation shield” or on the 

container used to hold the radioactive drug). 

AND 

Agree to affix the required labels to all “transport radiation 

shields” and to each container used to hold the 

radioactive drugs.

❒

❒

Radioactive Drug Shielding for Distribution

For each radioactive drug to be distributed (except for 

products intended for redistribution without manipulation and in 

the manufacturer’s original shipping package), provide 

the following: 

❒

 the radionuclide and the maximum activity for each type of 

container (e.g., vial, syringe) 

 a description of the type and thickness of the “transport 

radiation shield” provided for each type of container 

 the maximum radiation level to be expected at the surface 

of each “transport radiation shield” when the radioactive 

drug container is filled with the maximum activity 

Leak Tests 

State either of the following: 

“Leak test sample collection and analysis will be performed by 

an organization authorized by the NRC or an Agreement State 

to provide leak testing services to other licensees; or by using a 

leak test sample collection kit supplied by an organization 

licensed by the NRC or an Agreement State to provide leak test 

kits and sample analysis services to other licensees and 

according to the instructions provided in the leak test sample 

collection kit.”

❒

OR 

 
B–17 

Item 

No. Title and Criteria Yes

Description 

Attached

10. RADIATION SAFETY PROGRAM (Continued) 

“Leak testing and analysis will be done by the applicant.” 

Provide the information in Appendix I of this NUREG supporting 

a request to perform leak testing and sample analysis and 

either state that the applicant will follow the model procedures 

in Appendix I of NUREG–1556, Volume 13, Revision 2, 

“Consolidated Guidance About Materials Licensees: ProgramSpecific Guidance About Commercial Radiopharmacy 

Licenses” or submit alternative procedures.

❒ ❒ 

Security Program for Category 1 and Category 2 Materials 

In accordance with 10 CFR Part 37, licensees that possess an 

aggregated Category 1 or Category 2 quantity of radioactive 

material must establish, implement, and maintain an access 

authorization program and a security program to ensure 

physical protection of the radioactive material.

Need Not Be 

Submitted with 

Application

11. WASTE MANAGEMENT 

Pharmacy-generated Radioactive Wastes 

Submit the following statement:

“We have developed and will implement and maintain written 

procedures for waste management that meet the requirements 

in 10 CFR 20.1904(b), 10 CFR 20.2001(a), 10 CFR 20.2003, 

10 CFR 20.2006, 10 CFR 20.2108, 10 CFR 30.51, as 

applicable.” 

❒ 

AND

If the applicant wishes to compact and/or incinerate radioactive 

waste, then provide written procedures that will be implemented 

and maintained for compaction and/or incineration of 

radioactive waste.

 ❒ 

AND

If access to a radioactive waste burial site is unavailable, the 

applicant should request authorization for extended interim 

storage of waste. The applicant should use the references 

listed at the end of Section 8.11 of this NUREG for guidance 

and submit the required information with the application.

❒ ❒ 

 
B–18 

Item 

No. Title and Criteria Yes

Description 

Attached

11. WASTE MANAGEMENT 

Pharmacy-Generated Radioactive Wastes 

Returned Wastes from Customers 

 Submit the following statement: 

 “We have developed and will implement and maintain written 

procedures for customer return of pharmacy-supplied syringes 

and vials and their contents, to specify that: 

❒

 only pharmacy-supplied syringes and vials and their 

contents may be returned to the pharmacy 

 instructions will be provided to radiopharmacy customers for 

the proper preparation and packaging of the radioactive 

waste for return to the radiopharmacy 

 instructions will be provided to pharmacy staff for the 

pick-up, receipt, and disposal of the returned radioactive 

waste that meet the requirements in 10 CFR 20.2001(a), 

10 CFR 30.33, and 10 CFR 71.5, as applicable.”

 
1 APPENDIX C 

2 CHECKLIST FOR LICENSE APPLICATION

C–1 

1 Checklist for License Application 

2 C.1 Item 1: Action Type 

ACTION TYPE:

❒ New 

❒ Amendment 

❒ Renewal

ADMINISTRATIVE REVIEW:

❒ Current Guidance Used 

❒ References in Application Based on Current Regulations 

❒ All Attachments Referenced Included 

❒ Signature on Application

3 C.2 Item 2: Legal Identity 

NAME:

4 C.3 Items 2 & 3: Address 

STORAGE & LOCATION-OF-USE ADDRESS: MAILING ADDRESS:

5 C.4 Item 4: Person to Be Contacted About This Application 

CONTACT PERSON:

TELEPHONE NUMBER:

6 C.5 Item 5: Materials to Be Possessed 

Yes No Radionuclide

Form or 

Mfg/Model 

No. Quantity Purpose of Use

Specify Other Uses 

Not Listed on SSD 

Registration 

Certificate

 Byproduct 

Materials with 

Atomic No. 1-83 

Any ____ mCi per 

nuclide, 1 Ci 

total 

possession, 

except as 

noted: 

10 CFR 32.72 and 

10 CFR 30.41 

❒ Not applicable 

------------ 

❒ Uses are: 

 Molybdenum-99 Any ____ Ci 10 CFR 32.72 and 

10 CFR 30.41 

❒ Not applicable 

------------ 

❒ Uses are: 

 Technetium-99m Any ____Ci 10 CFR 32.72 and 

10 CFR 30.41 

❒ Not applicable 

------------ 

❒ Uses are: 
C–2 

Yes No Radionuclide

Form or 

Mfg/Model 

No. Quantity Purpose of Use

Specify Other Uses 

Not Listed on SSD 

Registration 

Certificate

 Iodine-131 Any ____ mCi 10 CFR 32.72 and 

10 CFR 30.41 

❒ Not applicable 

------------ 

❒ Uses are: 

 Fluorine-18 Any ____ mCi 10 CFR 32.72 and 

10 CFR 30.41 

❒ Not applicable 

------------ 

❒ Uses are: 

 Iodine-123 Any ____ mCi 10 CFR 32.72 and 

10 CFR 30.41 

❒ Not 

 applicable 

------------ 

❒ Uses are: 

 Xenon-133 Any ____Ci 10 CFR 32.72 and 

10 CFR 30.41 

❒ Not applicable 

------------ 

❒ Uses are: 

 Any Byproduct 

Material in a 

Brachytherapy 

Source, as listed in 

10 CFR 35.400 

Sealed 

Sources 

____ mCi 10 CFR 32.74 and 

10 CFR 30.41 

❒ Not applicable 

------------ 

❒ Uses are: 

 Any Byproduct 

Material in a 

sealed source for 

diagnosis, as listed 

in 10 CFR 35.500 

Sealed 

Sources 

 ____Ci per 

source and 

Ci total 

10 CFR 32.74 and 

10 CFR 30.41 

❒ Not applicable 

------------ 

❒ Uses are: 

 Any Byproduct 

Material in sealed 

sources in photonemitting remote 

afterloader units, 

teletherapy units, 

or gamma 

stereotactic 

radiosurgery units 

for therapeutic 

medical uses, as 

listed in 

10 CFR 35.600 

Sealed 

Sources 

____Ci per 

source and 

Ci total 

10 CFR 32.74 and 

10 CFR 30.41 

❒ Not applicable 

------------ 

❒ Uses are: 

 Any Byproduct 

Material or a 

radiation source 

approved for 

medical use that is 

not specifically 

addressed in 

subparts D 

through H of 

10 CFR Part 35, 

as listed in 

10 CFR 35.1000 

Any ____Ci per 

source and 

Ci total 

10 CFR 32.74 and 

10 CFR 30.41 

❒ Not applicable 

------------ 

❒ Uses are: 
C–3 

Yes No Radionuclide

Form or 

Mfg/Model 

No. Quantity Purpose of Use

Specify Other Uses 

Not Listed on SSD 

Registration 

Certificate

 Any byproduct 

material listed in 

10 CFR 31.11(a) 

Prepackage

d units for in 

vitro

diagnostic 

tests 

 ____mCi 10 CFR 31.11 ❒ Not applicable 

------------ 

❒ Uses are: 

 Any byproduct 

material 

authorized under 

10 CFR 35.65 

Sealed 

Sources 

 ____mCi Calibration and 

checking of the 

licensee’s 

instruments and 

10 CFR 32.74 and 

10 CFR 30.41 

❒ Not applicable 

------------ 

❒ Uses are: 

 DU Metal ____ kg Shielding for 

molybdenum-99/tec

hnetium-99m 

generators 

❒ Not applicable 

------------ 

❒ Uses are: 

 Cesium-137 Sealed 

sources in 

compatible 

device as 

specified in 

SSD 

registration 

sheet 

____Ci per 

source and 

____ 

Ci total 

Instrument 

calibration 

❒ Not applicable 

------------ 

❒ Uses are: 

 Other (specify) 

1 C.6 Item 6: Purpose of Use of Licensed Material 

Item Number and Title Suggested Response Yes 

Description 

Attached 

6.1 Distribution and Redistribution 

of Sealed and Unsealed 

Materials 

For all transferred, distributed, 

and redistributed sealed and 

unsealed materials:

 

 Provide a statement that, “We 

have developed and will 

implement and maintain written 

procedures to ensure 

compliance with the license 

verification requirements 

specified in 10 CFR 30.41(d).” 

❒ 

AND 

 Describe procedures to ensure 

that sealed and unsealed 

materials are securely and 

safely provided to mobile 

medical licensees if they are 

transferred, distributed, or 

redistributed to a mobile 

medical licensee’s mobile van 

or coach, and there is no 

permanent structure for 

byproduct material storage. For 

 ❒ 
C–4 

Item Number and Title Suggested Response Yes 

Description 

Attached 

example, procedures should 

ensure that delivery directly to 

the van will only occur if the van 

is occupied by mobile medical 

licensee personnel at the time 

of delivery. 

AND 

 Provide the following, as 

applicable: 

 

 For radiopharmaceuticals: 

 Confirm that 

radiopharmaceuticals will be 

prepared under the supervision 

of an Authorized Nuclear 

Pharmacist (ANP) or will be 

obtained from a supplier 

authorized pursuant to 10 CFR 

32.72, or under equivalent 

Agreement State requirements. 

❒ 

 Describe all licensed material to 

be distributed or redistributed. 

 ❒ 

 For generators: 

 Confirm that the generators will 

be obtained from a 

manufacturer licensed pursuant 

to 10 CFR 32.72, or under 

equivalent Agreement State 

requirements. 

❒ 

 Confirm that unused generators 

will be redistributed without 

opening or altering the 

manufacturer’s packaging. 

❒ 

 For redistribution of used 

generators: 

 

 Describe the procedures and 

instructions for safely 

repackaging the generators, 

including the use of the 

manufacturer’s original 

packaging and minimization of 

migration of radioactive fluids 

out of the generator 

during transport. 

 ❒ 

 Confirm that the manufacturer’s 

packaging and labeling will not 

be altered. 

❒ 

 Confirm that the generator will 

not be distributed beyond the 

expiration date shown on the 

generator label. 

❒ 
C–5 

Item Number and Title Suggested Response Yes 

Description 

Attached 

 Confirm that the redistributed 

generator will be accompanied 

by the manufacturer-supplied 

leaflet or brochure that provides 

radiation safety instructions for 

handling and using the 

generator. 

❒ 

 Confirm that only generators 

used in accordance with the 

manufacturer’s instructions will 

be redistributed. 

❒ 

 For Redistribution of Sealed 

Sources for Brachytherapy 

or Diagnosis: 

 

 Confirm that the sealed sources 

for brachytherapy or diagnosis 

to be redistributed will be 

obtained from a manufacturer 

authorized to distribute sealed 

sources for brachytherapy or 

diagnosis in accordance with a 

specific license issued pursuant 

to 10 CFR 32.74 or under 

equivalent Agreement State 

requirements. 

❒ 

 Confirm that the manufacturer’s 

packaging, labeling, and 

shielding will not be altered and 

that redistributed sources will be 

accompanied by the 

manufacturer-supplied package 

insert, leaflet, brochure, or other 

document that provides 

radiation safety instructions for 

handling and storing 

the sources. 

❒ 

 For Redistribution of Calibration 

and Reference Sealed Sources: 

 

 Confirm that calibration and 

reference sealed sources to be 

redistributed to medical use 

licensees will be obtained from 

a person licensed pursuant to 

10 CFR 32.74 to initially 

distribute such sources. 

❒ 

 Confirm that the manufacturer’s 

labeling and packaging will not 

be altered and that redistributed 

sources will be accompanied by 

the manufacturer-supplied 

calibration certificate and the 

leaflet, brochure, or other 

document that provides 

❒ 
C–6 

Item Number and Title Suggested Response Yes 

Description 

Attached 

radiation safety instructions for 

handling and storing the 

sources. 

 For Redistribution of 

Prepackaged Units for In Vitro

Tests: 

 

 Confirm that the prepackaged 

units for in vitro tests to be 

redistributed will be obtained 

from a manufacturer authorized 

to distribute the prepackaged 

units for in vitro tests in 

accordance with a specific 

license issued pursuant to 

10 CFR 32.71 or under an 

equivalent license of an 

Agreement State. 

❒ 

 For Redistribution of 

Prepackaged Units for In Vitro

Tests to General Licensees: 

 

 Confirm that the manufacturer’s 

packaging and labeling of the 

prepackaged units for in vitro 

tests will not be altered in any 

way. 

❒ 

 Confirm that each redistributed 

prepackaged unit for in vitro

tests will be accompanied by 

the manufacturer-supplied 

package insert, leaflet, or 

brochure that provides radiation 

safety instructions for general 

licensees. 

❒ 

 For Redistribution of 

Prepackaged Units for In Vitro

Tests to Specific Licensees: 

 

 Confirm that the labels, package 

insert, leaflet, brochure, or other 

documents accompanying the 

redistributed prepackaged units 

for in vitro tests will NOT 

reference general licenses, 

exempt quantities, or NRC’s 

regulations that authorize a 

general license (e.g., 10 CFR 

31.11). 

❒ 

 Confirm that the labeling on 

redistributed prepackaged units 

for in vitro tests will conform to 

the requirements of 

10 CFR 20.1901, “Caution 

signs” and 20.1904, “Labeling 

containers.” 

❒ 
C–7 

Item Number and Title Suggested Response Yes 

Description 

Attached 

 For Redistribution of Discrete 

Sources of radium-226: 

 

 Confirm that the discrete 

sources of radium-226 will be 

obtained by a manufacturer 

authorized to distribute it. 

❒ 

 Confirm that the manufacturer’s 

packaging, labeling, and 

shielding will not be altered and 

that redistributed sources will be 

accompanied by the 

manufacture-supplied package 

insert, leaflet, brochure, or other 

document that provides 

radiation safety instructions for 

handling and storing sources. 

❒ 

6.2 Preparation of 

Radiopharmaceuticals 

For radiopharmaceutical 

preparation, we will perform: 

 

 compounding of iodine-131 

capsules 

❒ 

 radioiodination ❒ 

 chemical synthesis of 

Positron Emission 

Tomography (PET) 

radiopharmaceuticals 

❒ 

 technetium-99m kit 

preparation 

❒ 

 other, specify ❒ ❒ 

6.3 Sealed Sources for Calibration 

and Checks and Possession of 

Discrete Sources of Radium226 and Depleted Uranium 

Supply specific information 

concerning the use of discrete 

sources of radium-226, sealed 

sources for reference and 

calibration, and DU shielding. 

❒

6.4 Service Activities We will provide customers the 

following radiation protection 

services involving licensed 

material: 

 

 leak testing ❒

 instrument calibration ❒

 other, specify ❒ ❒

 
C–8 

1 C.7 Item 7: Individual(s) Responsible for Radiation Safety Program and Their 

2 Training and Experience 

Item Number and Title Suggested Response Yes 

Description 

Attached 

7. Individual(s) Responsible for 

Radiation Safety Program and 

Their Training and Experience 

An organizational chart 

describing the management 

structure, reporting paths, and 

the flow of authority between 

executive management and the 

RSO. 

❒ ❒

7.1 RSO 

 Name: 

 _______________ 

A copy of the license (NRC or 

Agreement State) that 

authorized the uses requested 

and on which the individual was 

specifically named as the RSO, 

an ANP, or an AU; 

❒ ❒

OR 

Description of the training and 

experience demonstrating that 

the proposed RSO is qualified 

by training and experience as 

applicable to commercial 

nuclear pharmacies. 

❒ ❒ 

7.2 Authorized Nuclear 

Pharmacist(s) 

 Name(s): _____________ 

Name of the proposed ANP. ❒ ❒

AND 

Pharmacist’s license number 

and issuing entity; 

❒ ❒

AND 

For an individual previously 

identified as an ANP on an NRC 

or Agreement State license or 

permit or by a commercial 

nuclear pharmacy that has been 

authorized to identify ANPs 

(10 CFR 32.72(b)(2)(i)): 

 

Previous license number (if 

issued by NRC) or a copy of the 

license (if issued by an 

Agreement State) or a copy of a 

permit issued by an NRC master 

materials licensee, a permit 

issued by an NRC or Agreement 

State broad scope licensee, or a 

permit issued by an NRC Master 

Materials License broad scope 

permittee on which the individual 

was named an ANP or a copy of 

an authorization as an ANP from 

❒ ❒
C–9 

Item Number and Title Suggested Response Yes 

Description 

Attached 

a commercial nuclear pharmacy 

that has been authorized to 

identify ANPs. 

OR 

For an individual qualifying 

under 10 CFR 32.72(b)(4):

 

 Documentation that the 

individual was a nuclear 

pharmacist preparing only 

radioactive drugs containing 

accelerator-produced 

radioactive material. 

❒ ❒

AND 

 Documentation that the 

individual practiced at a 

pharmacy at a Government 

agency or federally 

recognized Indian Tribe 

before November 30, 2007, 

or at all other pharmacies 

before August 8, 2009, or an 

earlier date as noticed by the 

NRC. 

❒ ❒

OR 

For an individual qualifying 

under 10 CFR 35.55(a):

 

 Copy of the certification(s) of 

the specialty board whose 

certification process has 

been recognized under 

10 CFR 35.55(a). 

❒ ❒

AND 

 Written attestation, signed 

by a preceptor ANP, that 

training and experience 

required for certification 

have been satisfactorily 

completed and that a level of 

competency sufficient to 

function independently as an 

ANP has been achieved. 

❒ ❒

AND 

 If applicable, description of 

recent related continuing 

education and experience as 

required by 10 CFR 35.59. 

❒ ❒
C–10 

Item Number and Title Suggested Response Yes 

Description 

Attached 

OR 

For an individual qualifying 

under 10 CFR 32.72(b)(2)(ii):

 

 Description of the training 

and experience specified in 

10 CFR 35.55(b) 

demonstrating that the 

proposed ANP is qualified 

by training and experience. 

❒ ❒

AND 

 Written attestation, signed 

by a preceptor ANP, that 

training and experience 

required for certification 

have been satisfactorily 

completed and that a level of 

competency sufficient to 

function independently as an 

ANP has been achieved. 

❒ ❒

AND 

 If applicable, description of 

recent related continuing 

education and experience as 

required by 10 CFR 35.59. 

❒ ❒

Notes: 

NRC Form 313A (ANP), 

“Authorized Nuclear Pharmacist 

Training and Experience and 

Preceptor Attestation [10 CFR 

35.55]” may be used to 

document training and 

experience for those individuals 

qualifying under 10 CFR 

35.55(a) or (b).

 
C–11 

Item Number and Title Suggested Response Yes 

Description 

Attached 

 Descriptions of training and 

experience will be reviewed 

using the criteria listed above. 

The NRC will review the 

documentation to determine if 

the applicable criteria in 

10 CFR 32.72(b)(2) are met. If 

the training and experience do 

not appear to meet the criteria, 

the NRC may request additional 

information from the applicant or 

may request the assistance of 

the ACMUI in evaluating such 

training and experience. 

 

7.3 Authorized User(s) 

 Name(s):__________________ 

For each proposed AU: 

Name of each proposed AU. ❒ ❒

AND 

 Types, quantities, and 

proposed uses of licensed 

material. 

❒ ❒

AND 

 A copy of license (NRC or 

Agreement State) on which 

the individual was 

specifically named as an AU 

for the types, quantities, and 

proposed uses of licensed 

materials. 

❒ ❒

OR 

 A copy of the permit 

maintained by a licensee of 

broad scope that identifies 

the individual as an AU for 

the types, quantities, and 

proposed uses of licensed 

materials. 

❒ ❒

OR 

 A description of the training 

and experience 

demonstrating that the 

proposed AU is qualified by 

training and experience to 

use the requested licensed 

materials. 

❒ ❒

 
C–12 

C.8 Item 8: Training for Individuals Working in or Frequenting Restricted Areas 

 (Instructions to Occupationally Exposed Workers and Ancilliary Personnel)

Item Number and Title Suggested Response Yes

Description 

Attached

8. Training for Individuals Working 

in or Frequenting Restricted 

Areas (Instructions to 

Occupationally Exposed 

Workers and Ancilliary 

Personnel) 

8.1 Occupationally Exposed 

Workers and Ancillary 

Personnel 

“We have developed and will 

implement and maintain written 

procedures for a training 

program for each group of 

workers, including topics 

covered, qualifications of the 

instructors, method of training, 

method for assessing the 

success of the training, initial 

training, and annual refresher 

training.” 

❒

8.2 Training for Personnel Involved 

in Hazardous Materials 

Package Preparation and 

Transport 

“We have developed and will 

implement and maintain written 

procedures for training 

personnel involved in hazardous 

materials package preparation 

and transport that meet the 

requirements in 49 CFR 

172.700, 49 CFR 172.702, and 

49 CFR 172.704, as applicable.” 

❒

8.3 Training for Supervised 

Individuals Preparing 

Radiopharmaceuticals 

The applicant’s program for 

training of supervised individuals 

preparing radiopharmaceuticals 

will be examined during 

inspections but should not be 

submitted in the license 

application. 

N/A 

 
C–13 

C.9 Item 9: Facilities and Equipment

Item Number and Title Suggested Response Yes

Description 

Attached

9. Facilities and Equipment Provide a copy of the 

registration or license from a 

State Board of Pharmacy as a 

pharmacy, or provide evidence 

that the facility is operating as a 

nuclear pharmacy within a 

Federal medical institution. 

❒ ❒

AND 

Describe the facilities and 

equipment to be made available 

at each location where 

radioactive material will be used. 

A diagram should be submitted 

that shows the applicant’s entire 

facility and identifies activities 

conducted in all contiguous 

areas surrounding the facility. 

Diagrams should be drawn to a 

specified scale, or dimensions 

that are indicated. 

❒ ❒

Include the following 

information: 

 

 Descriptions of the area(s) 

assigned for the production 

or receipt, storage, 

preparation, measurement, 

distribution of radioactive 

materials, and the 

location(s) for radioactive 

waste storage. 

❒ ❒

 Sufficient detail in the 

diagram to indicate locations 

of shielding, the proximity of 

radiation sources to 

unrestricted areas, and other 

items related to radiation 

safety. 

❒ ❒

 A general description of the 

ventilation system, including 

representative equipment 

such as gloveboxes or fume 

hoods. (Note: Pertinent 

airflow rates, differential 

pressures, filtration 

equipment, and monitoring 

systems should be 

described in terms of the 

❒ ❒
C–14 

Item Number and Title Suggested Response Yes

Description 

Attached

minimum performance to be 

achieved.) 

 Confirmation that such 

systems will be employed for 

the use or storage of 

radioactive materials that 

are likely to become 

airborne, such as 

compounding radioiodine 

capsules and dispensing 

radioiodine solutions. 

❒ ❒ 

 Verification that ventilation 

systems ensure that 

effluents are ALARA, are 

within the dose limits of 

10 CFR 20.1301, and are 

within the constraint for air 

emissions established under 

10 CFR 20.1101(d). 

❒

 Mark drawings, diagrams, 

and descriptions that provide 

the exact location of 

materials or depict specific 

locations of security 

equipment as, 

“Security-Related 

Information–Withhold under 

10 CFR 2.390.” 

❒

For PET Radiopharmacies 

Provide a copy of the 

registration or license from a 

State Board of Pharmacy as a 

pharmacy, or provide evidence 

that the facility is operating as a 

nuclear pharmacy within a 

Federal medical institution. 

❒ ❒

AND 

Describe the facilities and 

equipment to be made available 

at each location where 

radioactive material will be used, 

which includes the method and 

shielding used to physically 

transfer licensed material (e.g., 

transfer lines) to the different 

processes (e.g., chemical 

synthesis, dispensing). 

❒ ❒
C–15 

Item Number and Title Suggested Response Yes

Description 

Attached

AND 

Provide a diagram that shows 

the entire facility and identifies 

activities conducted in all 

contiguous areas surrounding 

the facility. Diagrams should be 

drawn to a specified scale, or 

dimensions should be indicated. 

Include the following 

information:

❒ ❒

 Descriptions of the area(s) 

assigned for the production 

or receipt, storage, 

preparation, measurement, 

and distribution of 

radioactive materials and the 

location(s) for radioactive 

waste storage. 

❒ ❒ 

 Sufficient detail in the 

diagram to indicate locations 

of shielding and/or shielding 

equipment (e.g., hot cells for 

positron-emitting 

radionuclides), the proximity 

of radiation sources to 

unrestricted areas, and other 

items related to radiation 

safety, such as remote 

handling equipment and 

area monitors. 

❒ ❒

 A general description of the 

ventilation system, including 

representative equipment, 

such as glove boxes or fume 

hoods. Pertinent airflow 

rates, differential pressures, 

filtration equipment, and 

monitoring systems should 

be described in terms of the 

minimum performance to be 

achieved. Confirm that such 

systems will be employed for 

the production, use, or 

storage of radioactive 

materials. 

❒ ❒
C–16 

Item Number and Title Suggested Response Yes

Description 

Attached

 Verification that ventilation 

systems ensure that 

effluents are ALARA, are 

within the dose limits of 

10 CFR 20.1301, and are 

within the ALARA 

constraints for air emissions 

established under 

10 CFR 20.1101(d). 

❒ ❒

 
C–17 

1 C.10 Item 10: Radiation Safety Program

Item Number and Title Suggested Response Yes

Description 

Attached

10. Radiation Safety Program 

10.1 Audit and Review of Program 

The applicant’s program for 

reviewing the content and 

implementation of its Radiation 

Protection Program will be 

examined during inspections, 

but it should not be submitted in 

the license application. 

N/A 

10.2 Radiation Monitoring 

Instruments 

 A statement that: “We will 

use calibrated and operable 

equipment that is capable of 

detecting the type(s) of 

radiation being monitored 

and energy or energy range 

of the radiation being 

measured.” 

❒

OR 

 A description of the 

calibrated and operable 

instrumentation that will be 

used to perform radiation 

monitoring (e.g., portable or 

stationary count rate meters, 

LSCs, well-type scintillation 

counters, air monitors) 

❒

AND 

 A statement that: “We 

reserve the right to upgrade 

our monitoring 

instrumentation as 

necessary as long as the 

instruments are adequate to 

measure the type and level 

of radiation for which they 

are used.” 

❒

AND 

 If calibration is performed by 

a person or firm outside the 

applicant’s organization, 

specify that the calibration 

will be performed by an NRC 

or Agreement State licensee 

specifically authorized to 

perform instrument 

calibration as a service to 

other licensees. 

❒

OR 
C–18 

Item Number and Title Suggested Response Yes

Description 

Attached

 If the calibration is to be 

performed in-house, submit 

the instrument calibration 

procedure that will be used. 

In addition, identify the 

qualifications of the 

individuals who will perform 

the calibrations. 

❒

10.3 Material Receipt and 

Accountability 

“We will develop, implement, 

and maintain written procedures 

for safely opening packages that 

meet the requirements in 

10 CFR 20.1906.” 

❒

AND 

“We will conduct physical 

inventories of sealed sources of 

licensed material at intervals not 

to exceed 6 months.” 

❒

AND 

“We will develop, implement, 

and maintain written procedures 

for licensed material 

accountability and control to 

ensure that: 

❒

 License possession limits 

are not exceeded. 

 

 Licensed material in storage 

is secured from 

unauthorized access or 

removal. 

 

 Licensed material not in 

storage is maintained under 

constant surveillance and 

control. 

 

 Records of receipt (either 

from the licensee’s own 

production operations or 

from another licensee), 

transfer, and disposal of 

licensed material are 

maintained.” 

 

10.4 Occupational Dosimetry Provide one of the following 

statements: 

 
C–19 

Item Number and Title Suggested Response Yes

Description 

Attached

“We will maintain, for inspection 

by the NRC, documentation 

demonstrating that unmonitored 

individuals are not likely to 

receive a radiation dose in 

excess of the limits in 

10 CFR 20.1502.” 

❒

OR 

“We will monitor individuals in 

accordance with the criteria in 

the section titled, ‘Radiation 

Safety Program–Occupational 

Dose’ in NUREG–1556, Vol. 13, 

Rev. 2, “Consolidated Guidance 

About Materials Licenses: 

Program-Specific Guidance 

About Commercial 

Radiopharmacy Licenses.”

❒

OR, IN LIEU OF THESE 

STATEMENTS 

 ❒

Provide a description of an 

alternative method for 

demonstrating compliance with 

the referenced regulations.

10.5 Public Dose The applicant’s program to 

control doses received by 

individual members of the public 

will be examined during 

inspection, but it should not be 

submitted in a license 

application. 

N/A 

10.6 Safe Use of 

 Radionuclides and 

 Emergency Procedures 

“We have developed and will 

implement and maintain written 

procedures for the safe use of 

radioactive materials that 

address: 

❒

 Facility and personnel 

radioactive contamination 

minimization, detection, and 

control. 

 

 Performing molybdenum-99 

breakthrough measurements 

of each eluate of a 

molybdenum-99/technetium99m generator. 

 

 Use of protective clothing 

and equipment by 

personnel that meet the 

 
C–20 

Item Number and Title Suggested Response Yes

Description 

Attached

requirements in 

10 CFR 20.1101, 

10 CFR 20.1801, 

10 CFR 20.1802, 

10 CFR 30.34(g), and 

10 CFR 19.11(a)(3), as 

applicable.”

AND 

“We have developed and will 

implement and maintain written 

procedures for identifying and 

responding to emergencies 

involving radioactive material, 

including: 

❒

 Lost, stolen, or missing 

licensed material. 

 

 Exposures to personnel and 

the public in excess of NRC 

regulatory limits. 

 

 Releases of licensed 

materials in effluents and the 

sanitary sewer in excess of 

NRC regulatory limits. 

 

 Excessive radiation levels or 

radioactive material 

concentrations in restricted 

or unrestricted areas. 

 

 Radioactive spills and 

contamination. 

 

 Fires, explosions, and other 

disasters with the potential 

for the loss of containment 

of licensed material. 

 

 Routine contacts with local 

fire departments and LLEA 

that meet the requirements 

in 10 CFR 20.1101, 10 CFR 

20.2201- 20.2203, and 

10 CFR 30.50 and other 

requirements, as 

applicable.” For example, 

periodically contact the local 

fire departments and LLEAs 

to keep them informed about 

information they need to 

safely respond to 

emergency calls.. 

 
C–21 

Item Number and Title Suggested Response Yes

Description 

Attached

10.7 Surveys “We have developed and will 

implement and maintain written 

procedures for a survey program 

that includes: (1) performance of 

radiation and contamination 

level surveys in restricted and 

unrestricted areas, (2) personnel 

contamination monitoring, (3) 

action levels, (4) survey 

frequencies, and (5) 

maintenance of survey records 

that meet the requirements in 

10 CFR 30.53, 10 CFR 20.1501, 

and 10 CFR 20.2103, as 

applicable.” 

❒

10.8 Dosage Measurement 

Systems 

Describe the types of systems 

(measurement or combination of 

measurement and calculation) to 

be used for the measurement of 

alpha-, beta-, gamma-, and 

photon-emitting radioactive 

drugs. 

❒ ❒

AND 

For each dosage measurement 

system used to measure the 

amount of radioactivity in alpha-, 

beta-, gamma-, and 

photon-emitting radioactive 

drugs, state: “We have 

developed, and will implement 

and maintain, a written 

procedure for the performance 

of dosage measurement system 

checks and tests that meet the 

requirements in 

10 CFR 32.72(c).” 

❒

AND 

If applicable, include a sample 

calculation for determining 

beta-correction factors for dose 

calibrators with ionization 

chambers. 

❒ ❒

OR 

If applicable, include a means 

for ensuring the accuracy of 

beta-correction factors supplied 

by the instrument manufacturer 

or other entity. 

❒ ❒
C–22 

Item Number and Title Suggested Response Yes

Description 

Attached

10.9 Transportation The applicant’s program for 

transportation will be examined 

during inspection, but it should 

not be submitted in a license 

application. 

N/A 

10.10 Minimization of 

 Contamination 

The applicant does not need to 

provide a response to this item 

under the following condition: 

NRC will consider that the 

criteria have been met if the 

applicant’s responses meet the 

criteria for the following sections 

of this NUREG: 

❒

 Facilities and Equipment 

 Radiation Safety 

Program-Safe Use of 

Radionuclides and 

Emergency Procedures 

 

 Radiation Safety 

Program-Surveys 

 

 Radiation Safety 

Program-Leak Testing 

 

 Waste Management 

10.11 Radioactive Drug Labeling 

for Distribution 

Describe all labels, indicating 

the colors to be used, that will 

accompany the products and 

describe where each label is 

placed (e.g., on the “transport 

radiation shield” or the container 

used to hold the radioactive 

drug). 

❒ ❒

AND 

Agree to affix the required labels 

to all “transport radiation shields” 

and each container used to hold 

the radioactive drugs.

❒ ❒ 

10.12 Radioactive Drug Shielding 

for Distribution 

For each radioactive drug to be 

distributed (except for products 

intended for redistribution 

without manipulation and in the 

manufacturer’s original shipping 

package), provide the following: 

 

 The radionuclide and the 

maximum activity for each 

type of container (e.g., vial, 

syringe). 

❒ ❒
C–23 

Item Number and Title Suggested Response Yes

Description 

Attached

 Describe the type and 

thickness of the “transport 

radiation shield” provided for 

each type of container. 

❒ ❒

 Indicate the maximum 

radiation level to be 

expected at the surface of 

each “transport radiation 

shield” when the radioactive 

drug container is filled with 

the maximum activity. 

❒ ❒

10.13 Leak Tests State either of the following: 

“Leak test sample collection and 

analysis will be performed by an 

organization authorized by the 

NRC or an Agreement State to 

provide leak testing services to 

other licensees; or by using a 

leak test sample collection kit 

supplied by an organization 

licensed by the NRC or an 

Agreement State to provide leak 

test kits and sample analysis 

services to other licensees and 

according to the instructions 

provided in the leak test sample 

collection kit.” 

❒ 

OR 

“Leak testing and analysis will 

be done by the applicant.” 

Provide the information in 

Appendix I of this NUREG 

supporting a request to perform 

leak testing and sample analysis 

and either state that the 

applicant will follow the model 

procedures in Appendix I of 

NUREG–1556, Volume 13, 

Revision 3, “Consolidated 

Guidance About Materials 

Licensees: Program-Specific 

Guidance About Commercial 

Radiopharmacy Licenses” or 

submit alternative procedures.

❒ ❒

 
C–24 

Item Number and Title Suggested Response Yes

Description 

Attached

10.14 Security Program for 

Category 1 and Category 2 

Materials 

In accordance with 10 CFR Part 

37, licensees that possess an 

aggregated Category 1 or 

Category 2 quantity of 

radioactive material must 

establish, implement, and 

maintain an access 

authorization program and a 

security program to ensure 

physical protection of the 

radioactive material. 

N/A 

 
C–25 

1 C.11 Item 11: Waste Management (Pharmacy-Generated Radioactive Wastes)

Item Number and Title Suggested Response Yes

Description 

Attached

11. Waste Management 

(Pharmacy-Generated 

Radioactive Wastes) 

“We have developed, and will 

implement and maintain written 

procedures for waste 

management that meet the 

requirements in 10 CFR 

20.1904(b), 10 CFR 20.2001(a), 

10 CFR 20.2003, 

10 CFR 20.2006, 

10 CFR 20.2108, and 10 CFR 

30.51, as applicable.” 

❒

AND 

If the applicant wishes to 

compact and/or incinerate 

radioactive waste, then provide 

written procedures that will be 

implemented and maintained for 

compaction and/or incineration 

of radioactive waste.

❒ ❒

AND 

If access to a radioactive waste 

burial site is unavailable, the 

applicant should request 

authorization for extended 

interim storage of waste. The 

applicant should use the 

references listed at the end of 

Section 8.11 of this NUREG for 

guidance and submit the 

required information with the 

application.

❒ ❒ 

11.1 Returned Wastes from 

Customers 

“We have developed and will 

implement and maintain written 

procedures for customer return 

of pharmacy-supplied syringes 

and vials and their contents, to 

specify that: 

❒

 Only pharmacy-supplied 

syringes and vials and their 

contents may be returned to 

the pharmacy. 

 

 
C–26 

Item Number and Title Suggested Response Yes

Description 

Attached

 Instructions will be provided 

to radiopharmacy customers 

for the proper preparation 

and packaging of the 

radioactive waste for return 

to the radiopharmacy. 

 

 Instructions will be provided 

to pharmacy staff for the 

pick-up, receipt, and 

disposal of the returned 

radioactive waste that meet 

the requirements in 

10 CFR 20.2001(a), 10 CFR 

30.33, and 10 CFR 71.5, as 

applicable.” 

 
1 APPENDIX D 

2 FORMATS FOR DOCUMENTING TRAINING AND EXPERIENCE FOR 

3 INDIVIDUALS RESPONSIBLE FOR RADIATION PROTECTION PROGRAM

D–1 

1 Formats for Documenting Training and Experience for Individuals 

2 Responsible for Radiation Protection Program 

3 Table D–1. Authorized User or Radiation Safety Officer Training and Experience in 

4 Handling Radionuclides

Name (Last, First, Initial) 

Location of 

Training Dates Title 

Total 

Hours 

Breakdown of Course in Clock Hours 

RPP BH IR INST REG 

 

 TOTALS 

5 RPP - Radiation Protection Principles BH - Biological Hazards 

6 IR - Ionizing Radiation Units & Characteristics INST - Radiation Detection 

7 Instrumentation 

8 REG - NRC Regulations and Standards 
D–2 

1 Table D–1. Authorized User or Radiation Safety Officer Training and Experience In 

2 Handling Radionuclides (Actual use of radionuclides under the supervision of an AU or RSO) 

Name (Last, First, Initial) 

Isotope(s) 

Used 

Physical 

Form 

Maximum Amount 

Used at Any One 

Time 

Location 

of Use 

Description of 

Experience* 

Total Hours of 

Experience 

 

3 *Description of experience 

4 1. Shipping, receiving, and performing related radiation surveys. 

5 2. Using and performing checks for proper operation of dose calibrators, radiation survey meters, 

6 and other instruments used to measure photon- and high-energy beta-emitting radionuclides. 

7 3. Using and performing checks for proper operation of instruments used to measure alpha- and 

8 low-energy beta-emitting radionuclides. 

9 4. Calculating, assaying, and safely preparing radioactive materials. 

10 5. Use of procedures to prevent or minimize contamination and/or use of proper decontamination 

11 procedures. 
D–3 

1 Documentation of Training and Experience to Identify an Individual on a 

2 License as an Authorized Nuclear Pharmacist 

3 (1) Experienced Authorized Nuclear Pharmacists (ANP) 

4 An applicant or licensee that wants to add an experienced ANP to its commercial 

5 radiopharmacy application or license only needs to provide evidence that the individual is listed 

6 as an ANP on a license issued by the U.S. Nuclear Regulatory Commission (NRC) or 

7 Agreement State, a permit issued by an NRC master materials licensee, a permit issued by an 

8 NRC or Agreement State broad scope licensee, or a permit issued by an NRC master materials 

9 broad scope permittee, and that the individual meets the recentness of training criteria 

10 described in 10 CFR 35.59, “Recentness of training.” The applicant may also provide evidence 

11 that the individual is identified as an ANP by a commercial nuclear pharmacy authorized to 

12 identify ANPs. For individuals who have been previously authorized by, but not listed on, the 

13 commercial nuclear pharmacy license, medical broad scope license, or Master Materials 

14 License medical broad scope permit, the applicant should submit either verification of previous 

15 authorizations granted or evidence of acceptable training and experience. 

16 (2) Experienced Nuclear Pharmacists Who Only Used Accelerator-Produced Nuclear 

17 Materials, or Discrete Sources of Radium-226, or Both, for Nuclear Pharmacy Uses 

18 During the implementation of the Energy Policy Act of 2005 (EPAct), the NRC “grandfathered” 

19 nuclear pharmacists that used only accelerator-produced radioactive materials, discrete sources 

20 of radium-226 (Ra-226), or both, for nuclear pharmacy uses under the NRC waiver of August 

21 31, 2005, when using these materials for the same uses. Nuclear pharmacists that used 

22 accelerator-produced radionuclides or discrete sources of Ra-226 during the effective period of 

23 the waiver do not have to meet the requirements of 10 CFR 35.59, or the training and 

24 experience requirements in 10 CFR 32.72(b)(2)(i) or (ii), for those materials and uses. 

25 The applicant or licensee that is designating one of these experienced individuals as an ANP 

26 under the provisions of 10 CFR 32.72(b)(2)(iii) should document that the individual used only 

27 accelerator-produced radionuclides, or discrete sources of Ra-226, for nuclear pharmacy uses 

28 during the effective period of the waiver and that the materials were used for the same uses 

29 requested. This documentation may be, but is not restricted to, evidence that the individual was 

30 listed on an Agreement State or non-Agreement State license or permit authorizing these 

31 materials for the requested uses. 

32 (3) Applications That Include Individuals for Authorized Nuclear Pharmacist Recognition 

33 by NRC 

34 Applicants should submit NRC Form 313A (ANP) to show that the individual meets the correct 

35 training and experience criteria in 10 CFR Part 35, “Medical use of byproduct material,” Subpart 

36 B. There are two primary training and experience routes to qualify an individual as an ANP. 

37 The first is by means of certification by a board recognized by the NRC and listed on the NRC 

38 Web site at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html) as 

39 provided in 10 CFR 35.55(a). 

40 Preceptor attestations must also be submitted for all individuals. The second route is by 

41 meeting the structured educational program, supervised work experience, and preceptor 

42 attestation requirements in 10 CFR 35.55(b). 
D–4 

1 (4) Recentness of Training 

2 The required training and experience, including board certification, described in 10 CFR Part 35, 

3 “Medical use of byproduct material,” must be obtained within the 7 years preceding the date of 

4 the application, or the individual must document having had related continuing education, 

5 retraining, and experience since obtaining the required training and experience. Examples of 

6 acceptable continuing education and experience include the following: 

7  successful completion of classroom and laboratory review courses that include radiation 

8 safety practices relative to the practice of nuclear pharmacy 

9  practical experience in nuclear pharmacy under the supervision of an ANP at the same 

10 or another licensed facility that is authorized as a nuclear pharmacy 

11 (5) General Instructions and Guidance for Filling Out NRC Form 313A Series 

12 If the applicant wishes to identify a license and it is an Agreement State license, the applicant 

13 should provide a copy of the license. If the applicant wishes to identify a Master Materials 

14 License permit, the applicant should provide a copy of the permit. If the applicant wishes to 

15 identify a preceptor who is authorized under a broad scope license or broad scope permit of a 

16 Master Materials License, the applicant should provide a copy of the permit issued by the broad 

17 scope licensee or permittee. Alternatively, the applicant may provide a statement signed by the 

18 RSO or chairperson of the Radiation Safety Committee similar to the following: “__________ 

19 (name of preceptor) is authorized under _______________ (name of licensee/permittee) broad 

20 scope license number__________ to be an ANP during ___________ (time frame).” 

21 INTRODUCTORY INFORMATION

22 Name of Individual

23 Provide the individual’s complete name so that the NRC can distinguish the training and 

24 experience received from that received by others with a similar name. 

25 Note: Do not include personal or private information (e.g., date of birth, Social Security 

26 Number, home address, personal cellular phone number) as part of the qualification 

27 documentation. 

28 State or Territory where Licensed 

29 Note that the NRC requires pharmacists to be licensed by a State or territory of the United 

30 States, the District of Columbia, or the Commonwealth of Puerto Rico to practice pharmacy. 

31 Requested Authorization(s)

32 Check all authorizations that apply and fill in the blanks as provided. 

33 Part I. Training and Experience 

34 There are always multiple pathways provided for each training and experience section. Select 

35 the applicable one. 
D–5 

1 Item 1. Board Certification

2 The applicant or licensee may use this pathway if the proposed nuclear pharmacist is certified 

3 by a board recognized by the NRC (to confirm that the NRC recognizes that board’s 

4 certifications, see NRC’s Web page at 

5 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html). 

6 Notes:

7  An individual that is board-eligible will not be considered for this pathway until the 

8 individual is actually board-certified. Further, individuals holding other board 

9 certifications not recognized by the NRC will not be considered for this pathway. 

10  The applicant or licensee must provide a copy of the board certification and completed 

11 attestation as indicated on the attached NRC Form 313A (ANP). 

12  As indicated on the form, additional information is needed if the board certification was 

13 obtained more than 7 years ago. 

14 Item 2. Structured Educational Program for a Proposed Authorized Nuclear Pharmacist 

15 This pathway is used for those individuals who do not meet the requirements for the board 

16 certification pathway and are not listed on the license as an ANP. 

17 The regulatory requirements refer to a structured educational program consisting of both 

18 (a) classroom and laboratory training, and (b) supervised practical experience in nuclear 

19 pharmacy. All hours credited to classroom and laboratory training must relate directly to 

20 radiation safety and safe handling of byproduct material and be allocated to one of the topics in 

21 10 CFR 35.55(b)(1)(i). 

22 The proposed ANP may receive the required classroom and laboratory training, and supervised 

23 practical experience at a single training facility or at multiple training facilities; therefore, space is 

24 provided to identify each location and date of training or experience. The date should be 

25 provided in the month/day/year (mm/dd/yyyy) format. Under the “classroom and laboratory 

26 training,” provide the number of clock hours spent on each of the topics listed in the regulatory 

27 requirements. 

28 The proposed ANP may obtain the required “classroom and laboratory training” in any number 

29 of settings, locations, and educational situations. For example, at some medical 

30 teaching/university institutions, a course may be provided for that particular need and taught on 

31 consecutive days. In other training programs, the period may be a semester or quarter as part 

32 of the formal curriculum. Also, the classroom and laboratory training may be obtained using a 

33 variety of other instructional methods. Therefore, the NRC will broadly interpret “classroom and 

34 laboratory training” to include various types of instruction, including online training, as long as it 

35 meets the specific clock hour requirements and the subject matter relates to radiation safety and 

36 safe handling of byproduct material for the uses requested. 

37 Under the “supervised practical experience in a nuclear pharmacy” section of the form, provide 

38 the number of clock hours for each topic. The supervised practical experience topics for the 

39 nuclear pharmacists include all the basic elements in the practice of nuclear pharmacy. 

40 Therefore, all the hours of supervised experience are allocated to these topics. 
D–6 

1 Note: As indicated on the form, additional information is needed if the training and/or 

2 supervised practical experience was completed more than 7 years ago. 

3 Part II. Preceptor Attestation

4 The NRC defines the term “preceptor” in 10 CFR 35.2, “Definitions,” to mean “an individual who 

5 provides, directs, or verifies training and experience required for an individual to become an AU, 

6 an authorized medical physicist, an authorized nuclear pharmacist, or a Radiation Safety 

7 Officer.” While the supervising individual for the practical experience in nuclear pharmacy may 

8 also be the preceptor, the preceptor does not have to be the supervising individual as long as 

9 the preceptor directs or verifies the training and experience required. The preceptor must attest 

10 in writing regarding the training and experience of any individual to serve as an authorized 

11 individual and attest that the individual has satisfactorily completed the appropriate training and 

12 experience criteria and has achieved a level of competency sufficient to function independently. 

13 This preceptor also has to meet specific requirements. 

14 The NRC Form 313A (ANP) Part II-Preceptor Attestation has two sections. The preceptor must 

15 select either the board certification or the structured educational program when filling out the 

16 first section on this page. The second and final section of the page requests specific 

17 information about the preceptor’s authorization to use licensed material in addition to the 

18 preceptor’s signature. If the preceptor is listed as an ANP on an Agreement State license or a 

19 permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement 

20 State broad scope licensee, or a permit issued by an NRC master materials broad scope 

21 permittee, the licensee should submit a copy of the Agreement State license or permit along 

22 with NRC Form 313A (ANP) to prove the individual is qualified to serve as a preceptor. 

 
D–7 

1 U.S. NUCLEAR REGULATORY COMMISSION FORM 313A (ANP) 

2 Please use the most current version of this form, which may be found at: 

3 http://www.nrc.gov/reading-rm/doc-collections/forms/
D–8 
D–9 
 
1 APPENDIX E 

2 TYPICAL DUTIES AND RESPONSIBILITIES OF THE 

3 RADIATION SAFETY OFFICER 

E–1 

1 Typical Duties and Responsibilities of The 

2 Radiation Safety Officer 

3 The Radiation Safety Officer’s (RSO’s) duties and responsibilities include ensuring radiological 

4 safety and compliance with U.S. Nuclear Regulatory Commission (NRC) and U.S. Department 

5 of Transportation (DOT) regulations and with the conditions of the license (see Figure E–1). 

6 Typically, these duties and responsibilities include ensuring that: 

7  General surveillance is provided over all activities involving radioactive material, 

8 including routine monitoring, special surveys, and responding to events. 

9  Security of radioactive material will be maintained at all times. For licensees possessing 

10 an aggregated Category 1 or Category 2 quantity of radioactive material, he or she will 

11 participate in the development and implementation of a security program for radioactive 

12 material in accordance with 10 CFR Part 37. A “Category 1 quantity of radioactive 

13 material” and a “Category 2 quantity of radioactive material” are defined terms in 10 CFR 

14 37.5, and the radionuclides referenced in these 10 CFR 37.5 definitions are listed in 

15 Appendix A to 10 CFR Part 37. 

16  Incidents are responded to, investigated, their cause(s) and appropriate corrective 

17 action(s) are identified, and timely corrective action(s) are taken. 

18  Proper authorities are notified of incidents such as damage, fire, or theft. 

19  Corrective actions are developed, implemented, and documented when violations of 

20 regulations or license conditions or program weaknesses are identified. 

21  All activities are immediately terminated following any unsafe condition or activity that is 

22 found to be a threat to public health and safety. 

23  He or she is the primary source of radiation protection information for personnel at all 

24 levels of responsibility. 

25  All radiation workers are properly trained. 

26  Procedures for the safe use of radioactive materials are developed and implemented. 

27  The licensee’s procedures and controls, based upon sound radiation protection 

28 principles, are periodically reviewed to ensure that occupational doses and doses to 

29 members of the public are as low as is reasonably achievable (ALARA). Documentation 

30 is maintained to demonstrate, by measurement or calculation, that the total effective 

31 dose equivalent (TEDE) to the individual member of the public likely to receive the 

32 highest dose from the licensed operation does not exceed the annual limit. 

33  Prospective evaluations are performed of occupational exposures, and those individuals 

34 likely to receive, in a year, a radiation dose in excess of 10 percent of the allowable limits 

35 that are provided personnel monitoring devices. 

36  When necessary, personnel monitoring devices are used and exchanged at the proper 

37 intervals, and records of the results of such monitoring are maintained. 
E–2 

1  The performance of fume hoods and gloveboxes used for volatile radioactive material 

2 work are monitored for proper operation. 

3  The receipt, opening, and delivery of all packages of radioactive material arriving at the 

4 nuclear pharmacy are overseen and coordinated. 

5  An inventory of all radioactive materials is maintained, and the types and quantities of 

6 radionuclides at the facility are limited to the forms and amounts authorized by the 

7 license. 

8  Sealed sources are leak-tested at required intervals. 

9  There is effective management of the radioactive waste program, including 

10 effluent monitoring. 

11  Packaging and transport of radioactive material is in accordance with all applicable 

12 DOT requirements. 

13  The current license document and all of the document(s) referenced in the last condition 

14 of the license are maintained. 

15  License amendment and renewal requests, and notifications of new authorized nuclear 

16 pharmacists (ANPs), authorized users (AUs), or other changes relative to the license are 

17 submitted in a timely manner. 

18  Radiation Safety Program audits are performed at least annually and documented. 

19  He or she acts as liaison to the NRC. 

20  All required records are properly maintained. 
E–3 

Figure E–1. Typical Duties and Responsibilities of the RSO 
E–4 

1 Model Delegation of Authority

2 Memo 

3 To: Radiation Safety Officer 

4 From: Chief Executive Officer 

5 Subject: Delegation of Authority 

6 You, _______________________________, have been appointed radiation safety officer and 

7 are responsible for ensuring the safe and secure use of radiation. You are responsible for 

8 managing the Radiation Protection Program; identifying radiation protection problems; initiating, 

9 recommending, or providing corrective actions; verifying implementation of corrective actions; 

10 stopping unsafe activities; and ensuring compliance with regulations. You are hereby delegated 

11 the authority necessary to meet those responsibilities, including prohibiting the use of byproduct 

12 material by employees who do not meet the necessary requirements and shutting down 

13 operations, when justified, to maintain radiation safety. You are required to notify management 

14 if staff does not cooperate and does not address radiation safety issues. In addition, you are 

15 free to raise issues with the U.S. Nuclear Regulatory Commission at any time. It is estimated 

16 that you will spend _____ hours per week conducting radiation protection activities. 

17 ____________________________________ ____________________ 

18 Signature of Management Representative Date 

19 I accept the above responsibilities, 

20 _____________________________________ ____________________ 

21 Signature of Radiation Safety Officer Date 

22 cc: Affected department heads 
1 APPENDIX F 

2 SUGGESTED COMMERCIAL RADIOPHARMACY AUDIT CHECKLIST

F–1 

1 Suggested Commercial Radiopharmacy Audit Checklist 

2 Note: All areas indicated in audit notes may not be applicable to every license and may not 

3 need to be addressed during each audit. For example, licensees do not need to address areas 

4 that do not apply to the licensee’s activities, and activities that have not occurred since the last 

5 audit need not be reviewed at the next audit. Effective audits include observations of licensed 

6 activities being conducted and staff demonstrations of how they would respond to normal and 

7 abnormal situations based on credible scenarios posed by the auditor. 

8 Date of This Audit _______________________ 

9 Date of Last Audit _______________________ 

10 Next Audit Date _______________________ 

11 Auditor _______________________ 

12 Date _________________________________ 

13 _______________________________________ 

14 (Signature) 

15 Management Review_______________________Date__________________________________ 

16 

17 ________________________________________ 

18 (Signature) 

19 Audit History

20 A. Last audit of this location conducted on (date) 

21 B. Were previous audits conducted annually? [10 CFR 20.1101] 

22 C. Were records of previous audits maintained? [10 CFR 20.2102, “Records of radiation 

23 protection programs”] 

24 D. Were any deficiencies identified during the last 2 audits or 2 years, whichever is longer? 

25 E. Were corrective actions taken? (Look for repeated deficiencies.) 
F–2 

1 Organization and Scope of Program

2 A. If the mailing address or places of use changed, was the license amended? 

3 [10 CFR 30.34] 

4 B. If ownership changed or bankruptcy filed, was the U.S. Nuclear Regulatory 

5 Commission’s (NRC’s) prior consent obtained or was the NRC notified? 

6 [10 CFR 30.34, “Terms and conditions of licenses or license conditions (L/C)”] 

7 C. Authorized Nuclear Pharmacists 

8 1. New Authorized Nuclear Pharmacist (ANP) since last audit? If so, does new 

9 ANP meet NRC training requirements? [10 CFR 32.72, 10 CFR 35.2, 

10 10 CFR 35.55(b)] 

11 2. If an individual began work as an ANP, was NRC notified within 30 days or was 

12 license amended? [10 CFR 32.72, 10 CFR 35.13(b), 10 CFR 35.14(a)] 

13 D. Radiation Safety Officer 

14 1. New Radiation Safety Officer (RSO) since last audit? If so, does new RSO meet 

15 NRC training requirements? 

16 2. If the RSO was changed, was license amended? 

17 3. Is RSO fulfilling his/her duties? 

18 4. To whom does RSO report? 

19 E. Authorized Users 

20 1. New authorized user (AU) since last audit? If so, does new AU meet NRC 

21 training requirements? 

22 2. If an AU was added, was license amended? 

23 F. If the designated contact person for NRC changed, was NRC notified? 

24 G. Type and quantity of byproduct material 

25 1. Does the license authorize all of NRC-regulated radionuclides possessed? 

26 2. Is actual possession of those radionuclides within the limits on the license? 

27 Facilities

28 A. Are facilities as described in NRC license application? 

29 B. If facilities have changed, has NRC license been amended? 
F–3 

1 Equipment and Instrumentation

2 A. Are there a sufficient number and type of instruments capable of detecting the type and 

3 energy of radiation(s)? 

4 B. Are instruments and equipment used for quantitative radiation measurements calibrated 

5 periodically for the radiation measured? [10 CFR 20.1501, “General”] 

6 C. Are calibration records maintained? [10 CFR 20.2103(a)] 

7 D. If instrument calibration is performed in-house, have appropriate calibration procedures 

8 been developed, implemented, and maintained? 

9 E. Is there sufficient shielding (L-block, etc.) for work with radionuclides? 

10 F. Are generators housed in a separate room and/or properly shielded to keep doses as 

11 low as is reasonably achievable (ALARA)? 

12 G. Are procedures established for identifying, evaluating, and reporting safety component 

13 defects? [10 CFR 21.21, “Notification of failure to comply or existence of a defect and its 

14 evaluation”] 

15 H. Dose Calibrators for Photon-Emitters [10 CFR 32.72(c)] 

16 1. Constancy, at least once each day before assay of patient dosages 

17 (plus or minus 10 percent)? 

18 2. Linearity, at installation and at required frequency (plus or minus 10 percent)? 

19 3. Geometry dependence, at installation (plus or minus 10 percent)? 

20 4. Accuracy, at installation and at required frequency (plus or minus 10 percent)? 

21 5. After repair, adjustment, or relocation of the dose calibrator, were appropriate 

22 tests above repeated? 

23 I. Dose Measurement Systems for Beta- and Alpha-Emitters [10 CFR 32.72(c)] 

24 1. Calibrated for each isotope used, with that isotope? 

25 2. Constancy, at least once each day before assay of patient dosages 

26 (plus or minus 10 percent)? 

27 3. Geometry dependence, at installation (plus or minus 10 percent)? 

28 4. Accuracy, at installation and at manufacturer’s recommended frequency 

29 (plus or minus 10 percent)? 

30 5. Linearity, at installation and at manufacturer’s recommended frequency 

31 (plus or minus 10 percent)? 
F–4 

1 6. After repair, adjustment, or relocation of the dose calibrator, were appropriate 

2 tests above repeated? 

3 Area Surveys and Contamination Control [10 CFR 20.1501]

4 A. Are area surveys being performed at applicable locations and required frequencies? Are 

5 records maintained? [10 CFR 20.2103, “Records of surveys”] 

6 B. Are removable contamination surveys being performed at applicable locations and 

7 required frequencies? Are records maintained? [10 CFR 20.2103] 

8 C. Was prompt and appropriate corrective action taken and documented when excess 

9 radiation or contamination levels were detected? 

10 Leak Tests

11 A. Was each sealed source leak tested every 6 months or at other prescribed intervals? 

12 B. Was the leak test performed according to the license? 

13 C. Are records of results retained with the appropriate information included? 

14 D. Were any sources found leaking and if yes, was the NRC notified? 

15 Sealed Source Inventory

16 A. Is a record kept showing the receipt of each sealed source? [10 CFR 30.51(a)(1)] 

17 B. Are all sealed sources physically inventoried every 6 months? 

18 C. Are records of inventory results with appropriate information maintained? 

19 Training and Instructions to Workers

20 A. Were all workers who are likely to exceed 1 mSv [100 mrem] in a year instructed per 

21 10 CFR 19.12, “Instruction to workers”? Was refresher training provided, as needed? 

22 Are records maintained? [10 CFR 30.34, “Terms and conditions of licenses”] 

23 B. Were other workers trained as needed (e.g., radiopharmacy technicians, AUs, 

24 couriers/drivers, ancillary personnel)? Are records maintained? [10 CFR 30.34] 

25 C. Are workers knowledgeable of applicable 10 CFR Part 20, radiation protection 

26 procedures, emergency response procedures, and license conditions? 

27 D. Was HAZMAT training provided, if required? [49 CFR 172.700, 49 CFR 172.701, 

28 49 CFR 172.702, 49 CFR 172.704] 
F–5 

1 Material Use Control and Transfer 

2 A. Are restricted and unrestricted areas delineated? 

3 B. Are radioactive materials that are stored in a controlled or unrestricted area secured 

4 from unauthorized access or removal? [10 CFR 20.1801] 

5 C. Are radioactive materials that are in a controlled or unrestricted area and not in storage 

6 controlled and maintained under constant surveillance? [10 CFR 20.1802] 

7 D. Are there procedures for receiving and opening packages? [10 CFR 20.1906, 

8 “Procedures for receiving and opening packages”] 

9 E. Is byproduct material transferred only to authorized recipients? 

10 [10 CFR 30.41; 10 CFR 32.71; 10 CFR 32.72, “Manufacture, preparation, or transfer for 

11 commercial distribution of radioactive drugs containing byproduct material for medical 

12 use under Part 35;” 10 CFR 32.74] 

13 F. Are records kept of receipt and transfer? [10 CFR 30.51, “Records”] 

14 G. For licensees possessing aggregated Category 1 or Category 2 quantities of radioactive 

15 materials referenced in Appendix A to 10 CFR Part 37, is the access program content 

16 and implementation reviewed at least annually in accordance with the requirements in 

17 10 CFR Part 37.33? 

18 H. For licensees possessing aggregated Category 1 or Category 2 quantities of radioactive 

19 materials referenced in Appendix A to 10 CFR Part 37, is the security program content 

20 and implementation reviewed at least annually in accordance with the requirements in 

21 10 CFR Part 37.55? 

22 Personnel Radiation Protection

23 A. Are ALARA considerations incorporated into the Radiation Protection Program? 

24 [10 CFR 20.1101(b)] 

25 B. Were prospective evaluations performed and documented showing that unmonitored 

26 individuals receive less than or equal to 10 percent of the limit? [10 CFR 20.1502(a)] 

27 Did these evaluations consider doses to minors [10 CFR 20.1502(a)(2)] and declared 

28 pregnant women [10 CFR 20.1502(a)(3)]? 

29 C. Did unmonitored individuals’ activities change during the year, which could put them 

30 over 10 percent of limit? 

31 D. If yes to C. above, was a new evaluation performed? 

32 E. Is external dosimetry required (individuals likely to receive greater than 10 percent of 

33 limit)? And is dosimetry provided to these individuals? 

34 1. Is the dosimetry supplier NVLAP-approved? [10 CFR 20.1501(c)] 

35 2. Are the dosimeters exchanged at the appropriate frequency? 
F–6 

1 3. Are dosimetry reports reviewed by the RSO when they are received? 

2 4. Are the records on NRC Forms or equivalent completed? [10 CFR 20.2104(d), 

3 10 CFR 20.2106(c)] 

4 a. NRC-Form 4 “Cumulative Occupational Dose History” completed? 

5 b. NRC-Form 5 “Occupational Dose Record for a Monitoring Period” 

6 completed? 

7 5. Declared pregnant worker/embryo/fetus 

8 a. If a worker declared her pregnancy, was compliance with 

9 10 CFR 20.1208, “Dose equivalent to an embryo/fetus,” achieved? 

10 b. Were records kept of the embryo/fetus dose? [10 CFR 20.2106(e)] 

11 F. Are individuals monitored for internal dose if they are likely to receive greater than 

12 10 percent of the annual limit on intake (ALI)? 

13 G. Are workers notified annually of their exposures? 

14 H. Are records of exposures, surveys, monitoring, and evaluations maintained? 

15 [10 CFR 20.2102, “Records of radiation protection programs;” 10 CFR 20.2103, 

16 “Records of surveys;” 10 CFR 20.2106, “Records of individual monitoring results”] 

17 I. If required by 10 CFR 20.2206, “Reports of individual monitoring,” were individual 

18 monitoring results reported annually to the NRC? 

19 Waste Management 

20 A. Waste storage areas 

21 1. Is storage area properly posted? [10 CFR 20.1902] 

22 2. Are containers properly labeled? [10 CFR 20.1904] 

23 B. Decay-in-Storage 

24 1. Do radionuclides being stored all have physical half-lives less than 120 days? 

25 2. Are radionuclides being segregated for storage according to half-life? 

26 3. Before waste is disposed of 

27 a. Is a survey performed at the container surface with an appropriate survey 

28 instrument set on its most sensitive scale, with no interposed shielding, to 

29 determine that its radioactivity cannot be distinguished from low background? 

30 b. Are all radiation labels removed or obliterated, as appropriate? 

31 4. Are records kept? 
F–7 

1 C. Disposal by release into sanitary sewerage. 

2 1. Is licensed material readily soluble (or readily dispersible biological material) in 

3 water? [10 CFR 20.2003, “Disposal by release into sanitary sewerage”] 

4 2. Does the quantity of licensed material that the licensee releases into the sewer 

5 each month averaged over the monthly volume of water released into the sewer 

6 not exceed the concentration specified in 10 CFR Part 20 Appendix B, Table 3? 

7 3. If more than one radionuclide is released, does the sum of the ratios of the 

8 average monthly discharge of a radionuclide to the corresponding limit in 10 CFR 

9 Part 20, Appendix B, Table 3, not exceed unity? 

10 4. Does the total quantity of licensed material released into the sanitary sewerage 

11 system in a year not exceed the limits specified in 10 CFR 20.2003(a)(4)? 

12 D. Transfer to Authorized Recipient 

13 1. Is waste being transferred to a person specifically authorized to receive it? 

14 [10 CFR 20.2001, “General requirements”] 

15 2. Is waste properly manifested? [10 CFR 20.2006] 

16 Receipt of Radioactive Waste from Customers 

17 A. Does returned waste consist only of items that contained radioactive materials that the 

18 radiopharmacy supplied (e.g., pharmacy supplied syringes, vials)? 

19 B. Are waste packages checked for removable contamination upon receipt? 

20 Effluents 

21 A. Are effluents from materials being maintained ALARA? 

22 B. Are fume hoods checked to confirm an adequate airflow? 

23 C. Is effluent monitored to determine activity being released? 

24 D. Are filters being used and maintained according to the manufacturer’s instructions and 

25 pharmacy procedures? 

26 Public Dose 

27 A. Are licensed activities conducted such that doses to members of the public from 

28 exposure to radioactive materials, such as radioactive effluents, are below 1 mSv 

29 [100 mrem] TEDE in a year? [10 CFR 20.1301(a)(1)] 

30 B. Was the constraint on air emissions met such that an individual member of the public will 

31 not receive a TEDE in excess of 0.1 mSv [10 mrem] in a year? [10 CFR 20.1101(d)] 

32 C. Have surveys and/or evaluations been performed per 10 CFR 20.1501(a)? 
F–8 

1 1. Have there been any changes to the facility, storage of licensed materials, or the 

2 amount and/or types of licensed activities? If so, was a new survey or reevaluation 

3 performed? 

4 D. Does the dose in unrestricted areas exceed 0.02 mSv [2 mrem] in any 1 hour? 

5 [10 CFR 20.1301(a)(2)] 

6 E. Are sufficient records maintained to demonstrate compliance? [10 CFR 20.2103; 

7 10 CFR 20.2107, “Records of dose to individual members of the public”] 

8 F. Are licensed materials stored in a manner that would prevent unauthorized access or 

9 removal? [10 CFR 20.1801] 

10 Use and Emergency Procedures

11 A. Are procedures for safe use of radioactive materials and emergency procedures 

12 developed and implemented? 

13 B. Do the procedures contain the required elements? 

14 C. Are radioactive materials being handled safely? 

15 D. Does the staff use protective clothing, personnel monitors, and other equipment as 

16 appropriate? 

17 E. Is assistance coordinated with outside agencies for emergency response 

18 (e.g., fire department)? 

19 F. Did any emergencies occur? 

20 1. If so, were they handled properly? 

21 2. Were appropriate corrective actions taken? 

22 3. Was NRC notification and reporting completed as required? [10 CFR 20.2201, 

23 “Reports of theft or loss of licensed material;” 10 CFR 20.2202, “Notification of 

24 incidents;” 10 CFR 20.2203; 10 CFR 30.50] 

25 Transportation

26 A. Are DOT Type A or other authorized packages used? [49 CFR 173.415, “Authorized 

27 Type A packages”] 

28 B. Are package performance test records on file? 

29 C. Does each package have two labels (e.g., Yellow-II) with transportation index (TI), 

30 Nuclide, Activity, and Hazard Class? [49 CFR 172 -Subpart E, “Labeling”] 

31 D. Are packages properly marked? [49 CFR 172- Subpart D, “Marking”] 

32 E. Are packages closed and sealed during transport? [49 CFR 173.412(a) – for Type A 

33 packages; 49 CFR 173.475(f)] 
F–9 

1 F. Are shipping papers properly prepared and used? [49 CFR 172 Subpart C, 

2 “Shipping Papers”] 

3 G. Do shipping papers contain proper entries? [Shipping name; Hazard Class; Identification 

4 Number (UN Number); Total Quantity; Package Type; Nuclide; Reportable Quantity 

5 (RQ); Physical and Chemical Form; Activity (SI units required); Category of Label; TI; 

6 Shipper’s Name, Certification, and Signature; Emergency Response Phone Number; 

7 Emergency Response Information; and Cargo Aircraft Only (if applicable)] 

8 [49 CFR 172-Subpart C, “Shipping Papers”] 

9 H. Are shipping papers within driver’s reach and readily accessible during transport? 

10 [49 CFR 177.817(e)] 

11 I. Are packages secured against movement? [49 CFR 177.834, “General requirements;” 

12 [49 CFR 177.842, “Class 7 (radioactive) material”] 

13 J. Are incidents reported to DOT? [49 CFR 171.15, “Immediate notice of certain 

14 hazardous materials incidents,” 49 CFR 171.16, “Detailed hazardous materials 

15 incident reports”] 

16 K. If Category 1 and 2 materials referenced in Appendix A to 10 CFR Part 37 are 

17 transported, are safety and security plans in accordance with 49 CFR Part 172, 

18 Subpart I (i.e., 49 CFR 172.800—Purpose and applicability, and 172.802—Components 

19 of a security plan) and 10 CFR Part 37, Subpart D, “Physical Protection in Transit”? 

20 Auditor’s Independent Survey Measurements (If Made)

21 A. Provide the type, location, results of measurements, and survey date. Also note the 

22 survey instrument used, serial number, calibration date. Does any radiation level 

23 exceed regulatory limits? [10 CFR 20.1501(a), 10 CFR 20.1301(a)(2)] 

24 Notification and Reports

25 A. Was any radioactive material lost or stolen? If so, were reports made? 

26 [10 CFR 20.2201, 10 CFR 30.50] 

27 B. Did any reportable incidents occur? Were reports made? 

28 [10 CFR 20.2202, 10 CFR 30.50] 

29 C. Did any overexposures or high radiation levels occur? If so, were they reported? 

30 [10 CFR 20.2203, 10 CFR 30.50] 

31 D. Were any packages received with surface contamination and/or external radiation levels 

32 that exceeded regulatory limits? If so, were they reported to the NRC? 

33 [10 CFR 20.1906(d)] 

34 E. If any events (as described in items A through D above) occurred, what was the root 

35 cause? Were appropriate notifications made and corrective actions taken? 

36 F. Is the management/RSO aware of the telephone number (301-816-5100) for the NRC 

37 Emergency Operations Center? 
F–10 

1 Posting and Labeling 

2 A. Is NRC-Form 3, “Notice to Workers” posted? [10 CFR 19.11, “Posting of notices to 

3 workers”] 

4 B. Are NRC regulations and license documents posted or is a notice posted? 

5 [10 CFR 19.11, 10 CFR 21.6, “Posting requirements;” Section 206 of Energy 

6 Reorganization Act of 1974] 

7 C. Are other posting and labeling requirements met? [10 CFR 20.1902, “Posting 

8 requirements;” 10 CFR 20.1904] 

9 Recordkeeping for Decommissioning

10 A. Are records kept of information important to decommissioning? [10 CFR 30.35(g)] 

11 B. Do records include all information outlined in 10 CFR 30.35(g)? 

12 Bulletins and Information Notices

13 A. Are NRC Bulletins, NRC Information Notices (INs), Office of NMSS 

14 Newsletters received? 

15 B. Was appropriate training and action taken in response? 

16 Special License Conditions

17 A. Was compliance with special license conditions achieved? 

18 Deficiencies Identified During Audit; Corrective Actions

19 A. Summarize problems/deficiencies identified during the audit. 

20 B. If problems/deficiencies were identified in this audit, describe corrective actions 

21 planned or taken to prevent recurrence. Include date(s) when corrective actions 

22 are implemented. 

23 C. Provide any other recommendations for improvement. 

24 Evaluation of Other Factors

25 A. Is senior management appropriately involved with the Radiation Protection Program 

26 and/or RSO oversight? 

27 B. Does the RSO have sufficient time to perform his/her radiation safety duties? 

28 C. Is there sufficient staff to support the Radiation Protection Program?
1 APPENDIX G 

2 GENERAL RADIATION MONITORING INSTRUMENT SELECTION 

3 GUIDELINES AND RADIATION INSTRUMENT CALIBRATION GUIDELINES

G–1 

1 General Radiation Monitoring Instrument Selection Guidelines and 

2 Radiation Instrument Calibration Guidelines 

3 Radiation Instrument Selection Guidelines 

4 Licensees must possess and use calibrated and operable radiation detection and measurement 

5 instruments that are sufficiently sensitive to detect and measure the type and energy of the 

6 radiation used. Applicants should consider the scope of activities that will be performed at their 

7 facility in order to determine the number and type of instruments necessary to support licensed 

8 activities. Licensees typically possess two or more portable or hand-held instruments to monitor 

9 radiological conditions, detect contamination, and perform package preparation and receipt 

10 surveys. Portable instrumentation includes ionization chambers as well as other 

11 instrumentation such as count-rate meters that are supported by a variety of handheld probes or 

12 detectors that can be used to detect various types of radiation. These include Geiger-Mueller 

13 (GM) detectors, sodium iodide (NaI) scintillation detectors, and plastic scintillation detectors. 

14 Additionally, licensees may possess stationary or fixed instrumentation, such as well-type 

15 scintillation counters, area monitors, stack monitors, or continuous air monitors. 

16 When deciding on which types of instruments are appropriate for the intended use, licensees 

17 may wish to consult with the instrumentation or equipment manufacturer or vendor to obtain 

18 specifications. The instrument should be capable of detecting the type of radiation (alpha, beta, 

19 gamma) and be sensitive to the energy or energy range of the radiation to be measured 

20 (e.g., keV, MeV). The characteristics of the instrument, including principles of operation and 

21 expected efficiency for the type and energy of the radiation being measured, should be 

22 understood by the licensee before use. 

23 Applicants may wish to consider the following instrument selection guidelines: 

24  Alpha emitters and low-energy beta emitters, such as carbon-14 and sulfur-35, are 

25 difficult to detect with GM probes. The detection efficiency generally is about 2 percent 

26 for low-energy beta emitters. Licensees should use the proper surveying method 

27 (e.g., speed and height above surface), in order to perform adequate surveys. 

28 Additionally, wipes should be taken and counted with a liquid scintillation counter (LSC) 

29 to verify potential removable contamination. 

30  Medium- to high-energy beta emitters, such as P-32 and Ca-45, can be detected with a 

31 pancake GM probe. The efficiency ranges from 15 percent to 40 percent, depending on 

32 the beta energy. 

33  Low-energy gamma emitters, such as I-125, can be detected with a NaI probe or a 

34 thin-window GM probe (pancake or thin end-window). If the NaI probe possesses a thin 

35 window and thin crystal, the detection efficiency is approximately 20 percent. If a 

36 pancake or thin end-window GM probe is used, the detection efficiency is significantly 

37 lower and care should be taken to ensure that the GM probe is capable of detecting any 

38 established action levels. 

39  Medium- to high-energy gamma emitters, such as I-131 or high-energy photon emitters, 

40 such as F-18, can be detected with either GM or NaI probes, depending on the required 

41 sensitivity. In general, the sensitivity of GM probes is much lower than for NaI probes. 
G–2 

1 Further guidance regarding instrumentation can be found in Chapter 9 of the Handbook of 

2 Health Physics and Radiological Health, Third Edition, Edited by Bernard Shleien, 

3 Lester A. Slaback, Jr., and Brian Kent Birky, 1998. 

4 Model Radiation Survey Instrument Calibration Program

5 Radiation Instrument Calibration Guidelines 

6 This appendix does not contain a step-by-step procedure for performing instrument calibrations. 

7 Instead, it provides general guidelines that licensees should consider when developing an 

8 instrument calibration program and when developing specific instrument calibration procedures. 

9 Licensees should refer to instrument manufacturer instructions and/or nationally recognized 

10 standards when developing instrument calibration procedures. 

11 When developing calibration procedures, licensees should consider the conditions under which 

12 calibrations will be performed, such as the space available to perform calibrations, any 

13 necessary shielding, and any anticipated radiation exposures to personnel and members of the 

14 public. Other considerations include the procurement of any necessary equipment, including 

15 appropriate radiation sources to perform calibrations. The calibration program should be 

16 designed to provide the desired or necessary degree of accuracy. 

17 Training 

18 Before independently calibrating radiation survey instruments, an individual should complete 

19 both classroom and on-the-job training as follows: 

20  Classroom training may be in the form of lecture, video, computer-based, or self-study 

21 and will cover the following subject areas: 

22 — principles and practices of radiation protection; 

23 — radioactivity measurements, monitoring techniques, and the use of radiation 

24 detection instruments; 

25 — mathematics related to the use and measurement of radioactivity; and 

26 — biological effects of radiation 

27  On-the-job training will consist of the following: 

28 — observing authorized personnel performing radiation survey 

29 instrument calibration; and 

30 — conducting radiation survey meter calibrations under the supervision and in the 

31 physical presence of an individual already authorized to perform calibrations
G–3 

1 Facilities and Equipment for Calibration of Dose Rate or Exposure Rate Instruments 

2 To reduce doses received by individuals not calibrating radiation survey instruments, 

3 calibrations will be conducted in an isolated area of the facility or at times when no one else 

4 is present. 

5 The calibration source used for calibrating dose and dose rate measuring instruments should be 

6 well-collimated, and the calibration area should be designed to minimize scatter of radiation, 

7 which could affect the calibration process. 

8 The calibration area should be appropriately controlled so that persons entering the area will be 

9 aware if a radiation source is in use. Evaluate posting of the calibration area with appropriate 

10 radiation warning signs, as required by Subpart J of 10 CFR 20. 

11 Individuals conducting calibrations of radiation survey instruments will wear assigned dosimetry. 

12 Individuals conducting calibrations will use a calibrated and operable radiation survey 

13 instrument to ensure that unexpected changes in exposure rates are identified and corrected. 

14 Frequency of Calibration of Radiation Measurement Instruments and Equipment 

15 A licensee committed to a routine or emergency radiation survey program should perform an 

16 acceptable calibration of all radiation measurement instruments and equipment at the frequency 

17 specified in NRC regulations, annually, or at the frequency recommended by the manufacturer, 

18 whichever period is shorter. 

19 Special calibrations should be performed at any time there is reason to believe that the 

20 operating characteristics of a radiation measurement instrument have changed, by repair or 

21 alteration, or whenever system performance is observed to change significantly. 

22 Routine maintenance of radiation measurements instruments should be performed as 

23 recommended by the manufacturer. 

24 Primary or secondary standard instruments used to calibrate radiation measurement 

25 instruments should be inspected frequently for consistency of performance. 

26 Calibration Sources for Dose and Dose Rate Measuring Instruments 

27 A radioactive sealed source(s) will be used for calibrating dose and dose rate measuring 

28 radiation survey instruments, and this source will have the following characteristics: 

29  The source should approximate a point source. 

30  Calibration fields from gamma sources should be known with an accuracy when 

31 compared to secondary or primary national standards of 5 percent for dose rates greater 

32 than or equal to 1.0 μGy/h [0.1 mrad/h] and 10 percent for dose rates less than 

33 1.0 μGy/h [0.1 mrad/h]. 

34  The source should contain a radionuclide that emits radiation of identical or similar type 

35 and energy as the environment in which the calibrated device will be used. 
G–4 

1  The source should be strong enough to give an exposure rate of at least 

2 7.7 microcoulomb per kilogram per hour [30 milliroentgen per hour] at 100 centimeters 

3 {e.g., 3.1 gigabecquerels [85 millicuries] of cesium-137 or 780 megabecquerels 

4 [21 millicuries] of cobalt-60}. 

5 Note: Inverse square and radioactive decay laws should be used to correct changes in 

6 exposure rate due to changes in distance or source decay. 

7 Calibration of Dose or Dose Rate Measuring Instruments 

8 There are three kinds of scales frequently used on dose and dose-rate survey meters. These 

9 are calibrated as follows: 

10  Linear readout instruments with a single calibration control for all scales should be 

11 adjusted at the point recommended by the manufacturer or at a point within the normal 

12 range of use. Instruments with calibration controls for each scale should be adjusted on 

13 each scale. After adjustment, check the response of the instrument at approximately 

14 20 percent and 80 percent of full scale. Instrument readings should be within ±× of the 

15 conventionally true value for the following ranges: 

16 — Background to 10 μGy/h [1.0 mrad/h]; ±× = ±30% 

17 — 10 μGy/h [1.0 mrad/h] to 1.0 mGy/h [100 mrad/h]; ±× = ±20% 

18 — 1.0 mGy/h [100 mrad/h] to 10 Gy/h [1,000 Rad/h]; ±× = ±10% 

19  Logarithmic readout instruments, which commonly have a single-readout scale 

20 spanning several decades, normally have two or more adjustments. Adjust the 

21 instrument for each scale according to site specifications or the manufacturer’s 

22 specifications. After adjustment, check the calibration at a minimum of one point on 

23 each decade. Instrument readings should have a maximum deviation from the 

24 conventionally true value as described for linear readout instruments. 

25  Digital readout instruments should be calibrated the same as linear 

26 readout instruments. 

27 Note: Readings above 50 microcoulomb per kilogram per hour [200 milliroentgen per hour] 

28 need not be calibrated, unless the licensee expects to make measurements at higher dose 

29 rates; regardless, such scales should be checked for operation and response to radiation. 

30 Calibration of Surface Contamination Measurement Instruments 

31 Instruments used to detect surface contamination usually consist of a count-rate meter and a 

32 detector that is appropriate for the type of radiation(s) being measured. 

33 The efficiency of radiation survey meters must be determined by using radiation sources 

34 with similar energies and types of radiation that users of the radiation survey instrument intend 

35 to measure. 

36 If each scale has a calibration potentiometer, the reading should be adjusted to respond to the 

37 calibration source at approximately 80 percent of full scale, and the response at approximately 

38 20 percent of full scale should be observed. If only one calibration potentiometer is available, 

39 the response should be adjusted at mid-scale on one of the scales, and response on the other 
G–5 

1 scales should be observed. The instrument efficiency factor (e.g., cpm/dpm) thus obtained 

2 should have a signal-to-noise ratio, including the compilation of source and instrument 

3 uncertainties, of ±× for the following ranges: 

4  alpha measurement

— Bq/cm2

 to 2.0 Bq/cm2 [60 to 12,000 dpm/100 cm2 5 ]; ±× = ±20% 

— 2.0 Bq/cm2

 to 200 Bq/cm2 [12,000 to 1,200,000 dpm/100 cm2 6 ]; ±× = ±10% 

7  beta measurement

— 0.05 Bq/cm2

 to 2.0 Bq/cm2 [300 to 12,000 dpm/100 cm2 8 ]; ±× = ±20% 

— 2.0 Bq/cm2

 to 200 Bq/cm2 [12,000 to 1,200,000 dpm/100 cm2 9 ]; ±x = ±10%

10 Calibration of Analytical Instruments Such as Liquid Scintillation Counters, Gamma 

11 Counters, Gas Flow Proportional Counters, and Multichannel Analyzers

12 Analytical instruments used to determine radioactivity in a sample may be specialized 

13 equipment according to the type of samples to be analyzed and the types and quantities of 

14 radioactivity to be measured. Typically, the sample sizes and activities are very small and can 

15 be difficult to measure. Sample collection and preparation may differ for the various analytical 

16 instruments, so manufacturer procedures and industry standard practices should be followed. 

17 Such analytical instruments should be calibrated in accordance with the manufacturer’s 

18 instructions. Analytical instruments typically require routine maintenance and verification 

19 procedures to ensure that they are operating properly when used. 

20 As with calibration of other radiation measurement instruments, calibration of analytical 

21 instruments use a radioactive sealed source(s). These should be suitable for the geometry of 

22 the sample(s) to be analyzed. The calibration source(s) should have a known activity(ies) and 

23 be of similar type and energy as the radioactive materials to be analyzed. The analysis should 

24 be sensitive enough to detect the lowest levels of radioactivity desired. Correction of results for 

25 quenching, self-absorption, and other factors may be required, depending on the analytical 

26 instrument, the samples type, and other environmental conditions. 

27 Model procedures for the calibration of LSCs, well-type scintillation counters, gas-flow 

28 proportional counters, and single or multi-channel analyzers are not provided in this document. 

29 For compliance with 10 CFR 20.1501(c), users should refer to manufacturers’ instructions 

30 and/or nationally recognized standards for instrument calibration information. In general, 

31 manufacturers’ instructions typically specify that for these types of instruments, calibration is 

32 expected to produce readings within plus or minus 20 percent of the actual values over the 

33 range of the instrument. The minimum detectable activity (MDA) for instruments used should be 

34 a fraction (10 to 50 percent) of the criteria that is to be met. 

35 General Guidelines for Calibrating Installed Radiation Detection Instrumentation 

36 Installed instruments are those that operate using line power and are not designed to be 

37 portable or hand-carried. Such equipment includes fixed-type area monitors. When developing 

38 calibration procedures for these types of instruments, licensees should refer to the manufacturer 

39 or vendor’s instructions and/or nationally recognized standards, such as American National 

40 Standards Institute (ANSI) N323D-2003, “American National Standard for Installed Radiation 

41 Protection Instrumentation,” January 27, 2003. 
G–6 

1 Calibration Records 

2 Calibration records for all radiation survey instruments should indicate the procedure used and 

3 the results of the calibration. The records should include the following: 

4  the owner or user of the radiation survey instrument 

5  a description of the radiation survey instrument that includes the manufacturer’s name, 

6 model number, serial number, and type of detector 

7  a description of the calibration source, including the exposure rate at a specified 

8 distance or activity on a specified date 

9  for each calibration point, the calculated exposure rate or count rate, the indicated 

10 exposure rate or count rate, the deduced correction factor (the calculated exposure rate 

11 or count rate divided by the indicated exposure rate or count rate), and the scale 

12 selected on the radiation survey instrument 

13  the exposure reading indicated with the radiation survey instrument in the “battery 

14 check” mode (if available on the instrument) 

15  for radiation survey instruments with external detectors, the angle between the radiation 

16 flux field and the detector (i.e., parallel or perpendicular) 

17  for radiation survey instruments with internal detectors, the angle between the radiation 

18 flux field and a specified surface of the instrument 

19  for radiation detectors with removable shielding, an indication of whether the shielding 

20 was in place or removed during the calibration procedure 

21  the exposure rate or count rate from a check source, if used 

22  the name and signature of the individual who performed the calibration and the date on 

23 which the calibration was performed 

24 The following information will be attached to the radiation survey instrument as a calibration 

25 sticker or tag: 

26  for dose and dose rate measuring instruments, the source radionuclide used to calibrate 

27 the radiation survey instrument (with correction factors) for each scale 

28  for surface contamination measurement instruments, the efficiency of the radiation 

29 survey instrument, for each radionuclide the instrument will be used to measure 

30 (if efficiency is not calculated before each use) 

31  for each scale or decade not calibrated, an indication that the scale or decade was 

32 checked only for function but not calibrated 

33  the date of calibration and the next calibration due date 

34  the apparent exposure rate or count rate from the check source, if used 
G–7 

1 General Guidelines for Calibrating Air Monitoring Instruments 

2 Air monitoring equipment consists of installed/fixed, portable, personal air monitoring 

3 instruments, and continuous air monitors. The quantity of airborne radioactive material can be 

4 determined by sampling or continuous monitoring. Sampling involves taking or collecting a 

5 sample of the air and then determining the amount of radioactivity in that sample. This type of 

6 sampling can be performed during special or infrequent operations that could involve airborne 

7 radioactivity or can be performed on a routine basis for a continuous or ongoing process. When 

8 performing sampling, it is important to accurately determine the volume of air sampled. 

9 Continuous monitoring is a real-time analysis of the amount of radioactivity present. Air 

10 sampling or monitoring can be used by licensees to evaluate potential exposures to workers 

11 and to evaluate effluents released from the facility that contribute to public dose. 

12 Guidance for NRC licensees can be found in NRC Regulatory Guide (RG) 8.25, Revision 1, “Air 

13 Sampling in the Workplace,” June 1992, as well as NUREG-1400, “Air Sampling in the 

14 Workplace,” September 1993, which is available at ADAMS Accession No. ML13051A671. 

15 When developing calibration procedures for these types of instruments, licensees should refer 

16 to the manufacturer or vendor’s instructions and/or nationally recognized standards, such as 

17 ANSI N323C-2009, “American National Standard for Radiation Protection Instrumentation Test 

18 and Calibration-Air Monitoring Instruments,” May 21, 2009. 

19 To assess accurately the air concentration of radioactive materials in a given location, the 

20 volume of air sampled and the quantity of contaminant in the sample must be determined. 

21 Accurate determination of the volume of air sampled requires standard, reproducible, and 

22 periodic calibration of the air metering devices that are used with air sampling instruments. 

23 Licensees can find guidance on total air sample volume calibration methods acceptable to NRC 

24 staff in the publication titled “Air Sampling Instruments,” which can be found in the 9th Edition, 

25 American Conference of Governmental Industrial Hygienists, 2001. This information is 

26 supplemented below. 

27 Frequency of Calibration of Air Sampling Equipment

28  A licensee committed to a routine or emergency air sampling program should perform an 

29 acceptable calibration of all airflow or volume metering devices at least annually (See 

30 Regulatory Guide 8.25, Rev. 1, “Air Sampling in the Workplace”). 

31  Special calibrations should be performed at any time there is reason to believe that the 

32 operating characteristics of a metering device have been changed, by repair or 

33 alteration, or whenever system performance is observed to have changed significantly. 

34  Routine instrument maintenance should be performed as recommended by 

35 the manufacturer. 

36  Primary or secondary standard instruments used to calibrate air sampling instruments 

37 should be inspected frequently for consistency of performance. 

 
G–8 

1 Error Limit for Measurement of Air Sample Volume

2 Most methods of calibrating airflow or air volume metering devices require direct comparison to 

3 a primary or secondary standard instrument to determine a calibration curve or a correction 

4 factor. An example of a primary standard is a spirometer that measures total air volume directly 

5 with high precision by liquid displacement. An example of a secondary standard is a wet-test 

6 meter that has been calibrated against a primary standard. 

7 The following are significant errors associated with determining the total air volume sampled: 

8 EC: The error in determining the calibration factor. (An acceptable estimate is the 

percentage error associated with the standard instrument used in the calibration.)1 9 

10 ES: Intrinsic error in reading the meter scale. (An acceptable estimate is the percentage 

11 equivalent of one-half of the smallest scale division, compared to the scale reading.) 

12 Et: The percentage error in measurement of sampling time that should be kept within 

13 1 percent. 

14 EV: The most probable value of the cumulative percentage error in the determination of the 

15 total air volume sampled. EV can be calculated from the following equation, provided 

16 there are no additional significant sources of errors: 

EV = [ES

2

 + EC

2 + Et2

]

1/2 17 

18 The most probable value of the cumulative error EV, in the determination of total volume, should 

19 be less than 20%. 

20 A sample calculation of the most probable value of the cumulative error in total volume 

21 measured is as follows: If accuracies of the scale reading, the calibration factor, and sample 

22 time are ±4, 2, and 1 percent, respectively, and there are no other significant sources of error, 

23 the cumulative error would be: 

EV = [42

 + 22 + 12]

1/2 24 = 4.58% or approx. 5% 

25 If there are significant differences in pressure and temperature between the calibration site 

26 and the sampling site, appropriate corrections should be made using the ideal gas laws 

27 provided below: 

28 Vs = V1 * (P1/760) * (273/T1) 

29 where Vs = volume at standard pressure and temperature (760 mm Hg and 273̊K) 

 

1

The calibration factor should be based on two kinds of determinations. First, correction factors should be 

determined at several flow rates distributed over the full-scale range. Each flow rate correction factor should be 

determined while adjusting flow rates upscale and again while adjusting flow rates downscale, and the two sets of 

data should be compared. Second, subsequent calibrations should compare the new correction factors to those 

determined during the previous calibration. If observed differences are significant compared to the overall volume 

error limit of 20 percent, licensees should include an additional error term in the calculation above. 
G–9 

1 V1 = volume measured at conditions P1 and T1

2 T1 = temperature of V1 in K 

3 P1 = pressure of V1 in mm Hg 

4 Documentation of Calibration of Air Metering Devices

5 The licensee should maintain records of all routine and special calibrations of airflow or volume 

6 metering devices, including the primary or secondary standard used, method employed, and 

7 estimates of accuracy of the calibrated metering devices. All instruments should be clearly 

8 labeled as to the date and results of the most recent calibration and should include the 

9 appropriate correction factors to be used. 

10 References: 

11  Regulatory Guide 8.25, Revision 1, “Air Sampling in the Workplace,” June 1992 

12  NUREG–1400, “Air Sampling in the Workplace,” September 1993 

13 (available at the ADAMS Accession No. ML13051A671) 

14  Health Physics and Radiological Health, 4th Edition. Edited by Thomas E. Johnson and 

15 Brian Kent Birky, 2012 

16  ANSI N323AB-2013, “American National Standard for Radiation Protection 

17 Instrumentation Test and Calibration, Portable Survey Instruments,” December 16, 2013 

18  “Air Sampling Instruments,” American Conference of Governmental Industrial Hygienists, 

19 9th Edition, 2001 

20  ANSI N323D-2003, “American National Standard for Installed Radiation Protection 

21 Instrumentation,” January 27, 2003 

22  ANSI N323C 2009, “American National Standard for Radiation Protection 

23 Instrumentation Test and Calibration Air Monitoring Instruments,” May 21, 2009 

APPENDIX H 

PUBLIC DOSE

H–1 

1 Public Dose 

2 This appendix describes methods for determining radiation doses to members of the public. 

3 Licensees must ensure that: 

4  The radiation dose received by individual members of the public does not exceed 

5 1 millisievert (mSv) [100 millirem (mrem)] in a calendar year resulting from the licensee’s 

6 possession and/or use of licensed materials. 

7  The radiation dose in unrestricted areas does not exceed 0.02 mSv [2 mrem] in any 

8 1 hour. 

9  Air emissions of radioactive materials do not result in doses greater than 0.1 mSv 

10 [10 mrem] per year total effective dose equivalent (TEDE). As required by Title 10 of the 

11 Code of Federal Regulations (10 CFR) 20.1101(d), if the licensee exceeds the 10 mrem 

12 per year air emission dose constraint, the licensee must report the exceedance as 

13 provided in 10 CFR 20.2203, and promptly take appropriate corrective action to ensure 

14 against recurrence. 

Members of the public include persons who live, work, study, or may be near locations where 

licensed material is used or stored and employees whose assigned duties do not include the 

use of licensed material but may work in the vicinity where such materials are used or stored. 

Doses to Members of the Public

INCLUDE doses from 

 radiation and/or radioactive material 

released by a licensee 

 sources of radiation under the control of a 

licensee 

 effluents from sources of licensed 

radioactive materials 

 licensed material in transportation or 

storage at the licensee’s facility 

DO NOT INCLUDE doses from 

 sanitary sewerage discharges from licensee 

action taken in accordance with 

10 CFR 20.2003 

 natural background radiation 

 medical administration of radioactive material 

including patients released under 10 CFR 

35.75 

 voluntary participation in medical research

Unrestricted areas are areas, access to which is neither limited nor controlled by the licensee. 

Typical unrestricted areas may include offices, shops, laboratories (where licensed material is 

not used or stored), areas outside buildings, property, and storage areas. 

 
H–2 

1 The licensee may show compliance with the annual dose limit for individual members of the 

2 public by 

3  demonstrating by measurement or calculation that the TEDE to the individual likely to 

4 receive the highest dose at the boundary of the unrestricted area does not exceed 

5 1 mSv [100 mrem] in a year 

6  demonstrating that the annual average concentration of radioactive material released in 

7 gaseous and liquid effluents at the boundary of the unrestricted area does not exceed 

8 the values specified in Table 2, “Effluent Concentrations,” of Appendix B, 

9 to 10 CFR Part 20 {The licensee also should show that if a member of the public was 

10 continuously present in an unrestricted area, the dose from external sources would not 

11 exceed 0.02 mSv [0.002 rem] in any 1 hour and 1 mSv [0.1 rem] in a year.} 

12 To perform a dose assessment, the licensee should identify all potential sources of external and 

13 internal radiation exposure to members of the public and all locations of use, transport, and 

14 storage of radioactive material at the facility. The licensee must then take radiation 

15 measurements or perform calculations to demonstrate compliance. 

16 Measurements

17 The licensee may use measurements to demonstrate that the average annual releases are 

18 within regulatory limits, as well as to demonstrate that the TEDE to the individual likely to 

19 receive the highest dose at the boundary of the unrestricted area does not exceed 1 mSv 

20 [100 mrem] in a year. These measurements may include 

21  dose rate surveys for radiation exposures from external radiation sources 

22  measurements of radionuclides in air and water effluent 

23 The method used to measure dose will depend on the nature of the radiation source. If the 

24 source of radiation is constant, it may be adequate to measure the dose rate and integrate it 

25 over time. If the source of radiation differs or changes over time, it may be necessary to 

26 perform continuous measurements. 

27 Radioactivity releases may be determined by effluent monitoring or by effluent sampling and 

28 analysis. Airborne effluents may be discharged when volatile materials are used, such as 

29 during iodinations, but the discharge itself usually is not continuous becausevolatile materials 

30 often are used periodically rather than continuously. Liquid effluents may be discharged 

31 continuously or may be stored and subsequently discharged on a batch basis. For each type of 

32 source and for each route of potential exposure, consider the location of measurement points, 

33 whether continuous or periodic monitoring is required, the frequency of sampling and 

34 measurement, and any additional information. For discharges of airborne radionuclides, for 

35 example, it may be necessary to obtain information on the efficiency of filters and the air flow 

36 rate of the discharge system, as well as meteorological data and the distance to the nearest 

37 individual member of the public. 
H–3 

1 Calculation Method

2 Using a calculation method, the licensee must determine the highest dose an individual is likely 

3 to receive at the boundary of the unrestricted area. The licensee must take into account the 

4 individual’s exposure from external sources and the concentration of radionuclides in gaseous 

5 and liquid releases. In practice, the licensee may wish to make conservative assumptions to 

6 simplify the dose calculation. 

7 The public dose limit applies to the individual who is likely to receive the highest dose from 

8 licensed operations. Therefore, the dose calculations must consider the location with the 

9 potential for the highest internal and external exposures. An extremely conservative calculation 

10 would assume that the individual was continuously present 24 hours a day, 365 days a year, or 

11 an occupancy factor of 1 (see Table H–1). If the result of the calculation using an occupancy 

12 factor of 1 demonstrates that the public dose limit is not exceeded, then there is no need for 

13 further evaluation. 

14 If, however, the licensee would rather choose a more realistic assumption of the individual’s 

15 occupancy at the points of highest internal and external exposures, then the licensee may use 

16 the occupancy factors in Table H–1 or may calculate a specific occupancy factor by determining 

17 the likely fraction of time that the individual is present. 

Table H–1. Standard Occupancy Factors 

Occupancy Factor Description

1 Work areas such as offices, laboratories, shops, and occupied space in 

nearby buildings or outdoor areas 

1/4 Corridors, lounges, elevators using operators, unattended parking lots 

1/16 Waiting rooms, rest rooms, stairways, unattended elevators, janitor’s 

closets, outside areas used only for pedestrians or vehicular traffic 

18 Records

19 In accordance with 10 CFR 20.2107, the licensee must maintain records to demonstrate 

20 compliance with the dose limit for individual members of the public, until the Commission 

21 terminates the license. In general, survey and monitoring records of ambient radiation and 

22 effluent radioactivity should be adequate. 

23 Records demonstrating the dose to an individual member of the public should identify the 

24 instruments used in the survey, the name of the surveyor, the date of the survey, the location of 

25 the survey(s), including a description or drawing of the area surveyed, survey results, and if 

26 applicable, the occupancy factors used and justification for their use. In addition, records 

27 demonstrating the dose to an individual member of the public that involve effluent sampling 

28 analysis should include information on concentrations of specific radionuclides, minimum 

29 detectable activity of the system, and the estimated uncertainty of measurements.

1 APPENDIX I 

2 MODEL LEAK TEST PROGRAM

I–1 

1 Model Leak Test Program 

2 Training 

3 Before allowing an individual to perform leak testing, the licensee must ensure that he or 

4 she has sufficient classroom and on-the-job training to show competency in performing leak 

5 testing and sample analysis independently. 

6 Classroom training may be in the form of lecture, videotape, or self-study and will cover the 

7 following subject areas: 

8  principles and practices of radiation protection 

9  radioactivity measurements, monitoring techniques, and instrument use 

10  mathematics and calculations used for measuring radioactivity 

11  biological effects of radiation 

12 Appropriate on-the-job-training consists of 

13  observing authorized personnel collecting and analyzing leak-test samples 

14  collecting and analyzing leak-test samples under the supervision, and in the physical 

15 presence of, an individual authorized to perform leak testing and sample analysis 

16 Facilities and Equipment

17  To ensure achieving the required sensitivity of measurements, analyze leak tests in a 

18 low-background area. 

19  Use a calibrated and operable survey instrument to check leak-test samples for gross 

20 contamination before they are analyzed. 

21  Analyze the leak-test sample using an instrument that is appropriate for the type of 

22 radiation to be measured [e.g., NaI(Tl)] well-counter system for gamma emitters, LSCs 

23 for beta mitters, and gas-flow proportional counters for alpha emitters). 

24  If the sensitivity of the counting system is unknown, the MDA should be determined. 

25 The MDA may be determined using the following formula: 

MDA =

2.71 + 4.65 ඥbkg ×t

t ×E

26 where MDA = minimum detectable activity in disintegrations per minute (dpm) 

27 bkg = background count rate in counts per minute (cpm) 

28 t = background counting time in minutes 

29 E = detector efficiency in counts per disintegration 
I–2 

1 For example: 

2 where bkg = 200 cpm 

3 E = 0.1 counts per disintegration (10 percent efficient) 

4 t = 2 minutes 

MDA = 

2.71 + 4.65 ඥ200 cpm × 2 minutes

2 × 0.1 = 

2.71 + 4.65 √400

0.2

=		

2.71 + 4.65ሺ20ሻ

0.2 		=		

2.71 + 93

0.2 		=		

95.71

0.2

=		

478.55 disintegrations

minute

becquerels ሺBqሻ		=		

1 disintegration

second

MDA =		

478.55 disintegration

minutes × 

minute

60 seconds = 7.976 Bq

5 Note: The MDA equation shown assumes that counting times for the background measurement 

6 and for the sample will be equal. MDA equations for nonequal counting times, as well as 

7 derivations of equations and discussions of limitations, can be found in “Decommissioning 

8 Health Physics—A Handbook for MARSSIM Users,” Eric W. Abelquist, published by Taylor & 

9 Francis Group, 2001. 

10 Frequency for Conducting Leak Tests of Sealed Sources 

11 Leak tests will be conducted at the frequency specified in the respective Sealed Source and 

12 Device registration certificate. If a sealed source is not registered, leak tests should be 

13 conducted at 6-month intervals, unless a different interval is established during the licensing 

14 process. Leak testing of sealed sources may be required by license condition. 

15 Procedure for Performing Leak Testing and Analysis 

16  For each source to be tested, list identifying information such as sealed source serial 

17 number, radionuclide, and activity. 

18  Use a radiation survey meter to monitor exposure. 

19  Use a separate wipe sample (e.g., cotton swab or filter paper) for each source. 

20  Number each wipe to correlate with identifying information for each source. 

21  Wipe the most accessible area where contamination would accumulate if the 

22 sealed source were leaking, but do not wipe the surface of a plated or foil source 

23 (see manufacturer’s instructions). 
I–3 

1  Select an instrument that is sensitive enough to detect 185 Bq [0.005 microcuries] of the 

2 radionuclide contained in the sealed source. 

3  Using the selected instrument, count and record background count rate. 

4  Check the instrument’s counting efficiency using a standard source of the same 

5 radionuclide as the source being tested or one with similar energy characteristics. The 

6 calibration source should be in the same configuration as the sample. Accuracy of 

7 standards should be within plus or minus 5 percent of the stated value and traceable to 

8 primary radiation standards such as those maintained by the National Institute of 

9 Standards and Technology (NIST). 

10  Calculate or determine the counting efficiency of the detector. 

Efficiency in cpm/Bq =

[(cpm from std) – (cpm from bkg)]

activity of std in Bq

11 where cpm = counts per minute 

12 std = standard 

13 bkg= background 

14 Bq = becquerel 

15  Count each wipe sample and determine the net count rate. 

16  For each sample, calculate and record estimated activity in Bq (or microcuries). The 

17 activity of the sample in becquerels may be calculated using the following formula: 

Activity of sample [Bq] = [(cpm from wipe sample) - (cpm from bkg)]

efficiency in cpm/Bq

18  Sign and date the list of sources, data, and calculations. Retain records for 3 years 

19 [under Title 10 of the Code of Federal Regulations (10 CFR) 20.2103(a)]. 

20  If the wipe test activity is 185 Bq [0.005 microcurie] or greater, notify the RSO, so that the 

21 source can be withdrawn from use and disposed of properly. Also notify the NRC as 

22 required by license condition and/or regulation. 

23 Reference:

24 NUREG-1556, Volume 18, “Program-Specific Guidance About Service Provider Licenses” 

1 APPENDIX J 

2 U.S. DEPARTMENT OF TRANSPORTATION REGULATIONS 

J–1 

1 U.S. Department of Transportation Regulations 

2 Note: The following list of U.S. Department of Transportation (DOT) regulations is provided to 

3 inform licensees about typical requirements that apply to the transportation of licensed material 

4 including the preparation of shipments of licensed material. Licensees should note that the list 

5 is incomplete in that not all potentially applicable requirements have been included. Also, 

6 transportation requirements change; therefore, licensees should consult the regulations for 

7 definitive information about current requirements. Additional information on transportation 

8 requirements may be found at the DOT Web site: http://www.dot.gov/. 

9  Table of Hazardous Materials and Special Provisions—49 CFR 172, Subpart B 

10 — 49 CFR 172.101—Hazardous Materials Table [proper shipping name, hazard 

11 class, identification number] 

12 — 49 CFR 172.101—List of Hazardous Substances and Reportable Quantities, 

13 Table 2 to Appendix A—Radionuclides 

14  Shipping Papers—49 CFR 172, Subpart C 

15 — 49 CFR 172.201—Preparation and retention of shipping papers 

16 — 49 CFR 172.202—Description of hazardous material on shipping papers 

17 — 49 CFR 172.203—Additional description requirements 

18 — 49 CFR 172.204—Shipper’s certification 

19  Marking—49 CFR 172, Subpart D 

20 — 49 CFR 172.300—Applicability 

21 — 49 CFR 172.301—General marking requirements for non-bulk packagings 

22 — 49 CFR 172.304—Marking requirements 

23 — 49 CFR 172.310—Class 7 (radioactive) materials 

24 — 49 CFR 172.324—Hazardous substances in non-bulk packagings [designation of 

25 “reportable quantities” with the letters “RQ”] 

26  Labeling—49 CFR 172, Subpart E 

27 — 49 CFR 172.400—General labeling requirements 

28 — 49 CFR 172.400a—Exceptions from labeling 

29 — 49 CFR 172.401—Prohibited labeling 

30 — 49 CFR 172.403—Class 7 (radioactive) material 

31 — 49 CFR 172.406—Placement of labels 

32 — 49 CFR 172.436—RADIOACTIVE WHITE-I label 

33 — 49 CFR 172.438—RADIOACTIVE YELLOW-II label 

34 — 49 CFR 172.440—RADIOACTIVE YELLOW-III label 
J–2 

1  Placarding—49 CFR 172, Subpart F 

2 — 49 CFR 172.500—Applicability of placarding requirements 

3 — 49 CFR 172.504—General placarding requirements 

4 — 49 CFR 172.516—Visibility and display of placards 

5 — 49 CFR 172.556—RADIOACTIVE placard 

6  Emergency Response Information—49 CFR 172, Subpart G 

7 — 49 CFR 172.600—Applicability and general requirements 

8 — 49 CFR 172.602—Emergency response information 

9 — 49 CFR 172.604—Emergency response telephone number 

10  Training—49 CFR 172, Subpart H 

11 — 49 CFR 172.702—Applicability and responsibility for training and testing 

12 — 49 CFR 172.704—Training requirements 

13  Safety and Security Plans—49 CFR 172, Subpart I 

14 — 49 CFR 172.800—Purpose and applicability 

15 — 49 CFR 172.802—Components of a security plan 

16  Shippers—General Requirements for Shipments and Packagings—49 CFR Part 173 

17 — 49 CFR 173.25—Authorized packagings and overpacks 

18 — 49 CFR 173.403—Definitions 

19 — 49 CFR 173.411—Industrial packages 

20 — 49 CFR 173.412—Additional design requirements for Type A packages 

21 — 49 CFR 173.413—Requirements for Type B packages 

22 — 49 CFR 173.415—Authorized Type A packages 

23 — 49 CFR 173.416—Authorized Type B packages 

24 — 49 CFR 173.433—Requirements for determining basic radionuclide values, and 

25 for the listing of radionuclides on shipping papers and labels 

26 — 49 CFR 173.435—Table of A1 and A2 values for radionuclides 

27 — 49 CFR 173.441—Radiation level limitations and exclusive use provisions 

28 — 49 CFR 173.471—Requirements for U.S. Nuclear Regulatory Commission 

29 approved packages 

30 — 49 CFR 173.475—Quality control requirements prior to each shipment of Class 7 

31 (radioactive) materials 

32 — 49 CFR 173.476—Approval of special form Class 7 (radioactive) materials 

33  Carriage by Public Highway—49 CFR Part 177 

34 — 49 CFR 177.817—Shipping papers 

35 — 49 CFR 177.842—Class 7 (radioactive) material [includes requirement for 

36 blocking and bracing during transport] 

37 Note: The following reference charts are for reference only and are not a substitute for DOT

38 and U.S. Nuclear Regulatory Commission transportation regulations. 
J–3 

 
J–4 

 
J–5 

 
J–6 

 
J–7 

 
J–8 

 
J–9 

 
J

–10 

1 
1 APPENDIX K 

2 MODEL PERSONNEL TRAINING PROGRAM

K–1 

1 Model Personnel Training Program 

2 Training Program 

3 1. General instructions 

4 1.1 Training will be provided 

5  before an employee assumes duties with or in the immediate vicinity of 

6 radioactive materials 

7  at least annually, as refresher training for all employees 

8  whenever a significant change occurs in duties, regulations, or the terms 

9 of a U.S. Nuclear Regulatory Commission (NRC) license 

10 1.2 Subjects covered for individuals working with, or in the vicinity of, radioactive 

11 materials or radiation 

12  safe radiation practices associated with the job (examples of topics that 

13 may be covered are found in Section 3 of this appendix) 

14  site-specific radiation safety practices 

15  applicable NRC regulations 

16 1.3 Subjects covered for ancillary personnel 

17  significance of the radiation symbol and its use on signs and labels 

18  location of unrestricted areas 

19  whether the individual is authorized access to the restricted areas of 

20 the facility 

21 1.4 Type of instruction 

22  Instruct individuals in the licensee’s site-specific Radiation Safety 

23 Program and NRC regulatory requirements in the form of lecture, 

24 demonstrations, videotape, or self-study, and include practical subjects 

25 important to the safe use of licensed material. 

26  Provide individuals receiving instructions an opportunity to ask questions. 

27 2. Instruction for individuals likely to receive an occupational dose in excess of 1 mSv 

28 [100 mrem] 

29 2.1 Instruction will be provided 

30  before an employee assumes duties with or in the immediate vicinity of 

31 radioactive materials 
K–2 

1  at least annually, as refresher training 

2  whenever a significant change occurs in duties, regulations, or terms of 

3 NRC license 

4 2.2 Licensees must provide instruction on subjects covered in 10 CFR 19.12, 

5 “Instruction to workers.” 

6 2.3 Records of initial and refresher training will be maintained and will include 

7  name of the individual who provided the instruction 

8  names of the individuals who received the instruction 

9  date of instruction 

10  list of the topics covered 

11 3. Suggested radiation safety training topics for individuals working with, or in the vicinity 

12 of, byproduct material (this section is intended as a guide to topics covered in a typical 

13 radiation safety training program; topics selected will be commensurate with the 

14 individuals’ duties). 

15 3.1 Basic radiation safety information 

16  basic radiation biology (e.g., interaction of ionizing radiation with cells 

17 and tissues) 

18  radiation safety 

19 — radiation vs. contamination 

20 — internal vs. external exposure 

21 — biological effects of radiation 

22 — as low as is reasonably achievable (ALARA) concept 

23 — use of time, distance, and shielding to minimize exposure 

24  risk estimates, including comparison with other health risks 

25 (10 CFR 19.12) 

26  regulatory requirements 

27 — RSO 

28 — material control and accountability 

29 — dose to individual members of the public 

30 — personnel dosimetry 

31 — occupational dose limits and their significance 

32 — dose limits to the embryo/fetus, including instruction on 

33 declaration of pregnancy 

34 — workers’ right to be informed of occupational radiation exposure 

35 — Radiation Safety Program audits 

36 — ordering and receipt of packages 

37 — transfer 

38 — waste disposal 

39 — security 
K–3 

1 — recordkeeping 

2 — surveys 

3 — postings 

4 — labeling of containers 

5 — handling and reporting of incidents or events 

6 — licensing and inspection by the NRC 

7 — need for complete and accurate information 

8 — employee protection 

9 — deliberate misconduct 

10 3.2 General topics for safe use of radionuclides 

11  Wear a laboratory coat or other protective clothing at all times when 

12 working with radioactive materials. 

13  Use syringe shields and vial shields when preparing and handling 

14 radioactive drugs. 

15  Measure all radiopharmaceuticals before transfer. 

16  Measure the molybdenum-99 content of each generator elution, and do 

17 not transfer those radiopharmaceuticals for human medical use that will 

18 contain more than 0.15 microcuries of molybdenum-99 per mCi of 

19 technetium-99m at the time of administration. 

20  Wear disposable gloves at all times when handling radioactive materials, 

21 and change gloves frequently to minimize the spread of contamination. 

22  Before leaving the hot lab, monitor hands, shoes, and clothing for 

23 contamination in a low-background area, allowing sufficient time for 

24 instrument response (e.g., move probe 2 inches per second a half-inch 

25 from the surface). 

26  Do not eat, drink, smoke, or apply cosmetics in any area where licensed 

27 material is stored or used. 

28  Do not store food, drink, or personal effects in areas where licensed 

29 material is stored or used (see Figure N-1 of this NUREG). Personal 

30 items brought into the restricted area (e.g., radios, portable music players, 

31 notepads, books) will be surveyed for contamination before removal from 

32 the area. 

33  Clearly label food and beverages used in the preparation of 

34 radiopharmaceuticals with “Not for personal consumption” if stored with 

35 radioactive materials. 

36  Wear personnel monitoring devices, if required, at all times while in areas 

37 where licensed materials are used or stored. 

38  Dispose of radioactive waste only in designated, labeled, and properly 

39 shielded receptacles. 
K–4 

1  Never pipette by mouth. 

2  Store radioactive solutions in clearly labeled containers. 

3  Secure all licensed material when it is not under the constant surveillance 

4 and immediate control of the user(s). 

5 3.3 Instruction on radiopharmacy-specific program elements 

6  applicable regulations and license conditions 

7  areas where radioactive material is used or stored 

8  potential hazards associated with radioactive material in each area where 

9 the individuals will work 

10  special procedures for handling volatile materials 

11  proper use of radiation shielding 

12  proper use of survey and analytical instruments 

13  appropriate response to spills, emergencies, or other unsafe conditions 

14  emergency procedures 

15  previous incidents, events, and accidents 

16  survey program 

17  effluent monitoring and control 

18  customer-returned waste pickup, receipt, and handling 

19  waste management and minimization 

20  personnel monitoring 

21  procedures for receiving packages containing radioactive materials 

22  procedures for opening packages 

23  sealed sources and leak tests 

24  other topics, as applicable
1 APPENDIX L 

2 DOSE CALIBRATOR TESTING GUIDANCE

L–1 

1 Dose Calibrator Testing Guidance 

2 Guidance for Testing Dose Calibrators Used to Measure Photon-Emitting 

3 Radionuclides 

4 This guidance can be used by applicants and licensees for checking and testing dose 

5 calibrators. Applicants and licensees should consider the need for additional testing for dose 

6 calibrators used to measure alpha- or beta-emitting radionuclides. 

7 Guidance 

8 1. Test for the following at the indicated frequency (if the dose calibrator falls outside the 

9 suggested tolerances, the dose calibrator should be repaired or replaced): 

10 1.1 Constancy, at least once each day before assay of patient dosages (a safe 

11 margin is considered to be below plus or minus 10 percent) 

12 1.2 Linearity at installation and at least quarterly thereafter (a safe margin is 

13 considered to be below plus or minus 10 percent) 

14 1.3 Geometry dependence at installation (a safe margin is considered to be below 

15 plus or minus 10 percent) 

16 1.4 Accuracy, at installation and at least annually thereafter (a safe margin is 

17 considered to be below plus or minus 10 percent) 

18 2. After repair, adjustment, or relocation of the dose calibrator, such that proper function of 

19 the ionization chamber or electronics would likely be in doubt, repeat the above tests as 

20 appropriate. 

21 3. Constancy means reproducibility in measuring a constant source over a long period of 

22 time. Assay at least one relatively long-lived source such as cesium-137, cobalt-60, 

23 cobalt-57, or radium-226, using a reproducible geometry each day before using the 

24 calibrator; consider using two or more sources with different photon energies and 

25 activities. 

26 3.1 Assay each reference source using the appropriate dose calibrator setting 

27 (e.g., use the cesium-137 setting to assay cesium-137). 

28 3.2 Measure background at the same setting, and subtract or confirm the proper 

29 operation of the automatic background circuit if it is used. 

30 3.3 For each source used, either plot or log (i.e., record in the dose calibrator log 

31 book) the background level for each setting checked and the net activity of each 

32 constancy source. 

33 3.4 Using one of the sources, repeat the above actions for all commonly used 

34 radionuclide settings. Plot or log the results. 
L–2 

1 3.5 Establish an action level or tolerance for each recorded measurement at which 

2 the individual performing the test will automatically notify the Authorized Nuclear 

3 Pharmacist (ANP) or the RSO of a suspected malfunction of the calibrator. 

4 These action levels should be written in the log book or posted on the calibrator. 

5 The dose calibrator will be repaired or replaced if the error exceeds 10 percent. 

6 4. The linearity of a dose calibrator should be ascertained over the range of its use 

7 between the maximum activity in a vial and 30 microcuries. Note that with radionuclides 

8 with short half-lives, such as PET radionuclides, there may be difficulties measuring a 

9 low activity such as 30 microcuries. Therefore, the lowest activity that is measurable, 

10 which must be below the lowest dose distributed, is acceptable. Linearity means that 

11 the calibrator is able to indicate the correct activity over the range of use of that 

12 calibrator. This example uses a vial of technetium-99m that has the anticipated 

13 maximum activity to be assayed (e.g., the first elution from a new generator) and 

14 assumes the predetermined safety margin is plus or minus 5 percent. 

15 4.1 Time Decay Method 

16 4.1.1 Inspect the instrument to ascertain that the measurement chamber liner 

17 is in place and that instrument zero is properly set (see manufacturer’s 

18 instructions). 

19 4.1.2 Assay the technetium-99m vial in the dose calibrator and subtract 

20 background to obtain net activity in mCi. 

21 4.1.3 Repeat step in Section 4.1.2 at time intervals of 6, 24, 30, and 48 hours 

22 after the initial assay. 

23 Note: Time intervals used for other radionuclides may vary depending on the 

24 radionuclide’s half-life. 

25 4.1.4 Using the 30-hour activity measurement as a starting point, calculate the 

26 predicted activities at 0, 6, 24, and 48 hours using the following table: 

Assay Time1

(hours) 

Correction 

Factor 

0 31.6 

6 15.8 

24 2.00 

30 1.00 

48 0.126 

 

1

Assay times should be measured in whole hours, and correction factors should be used to three significant figures 

as indicated. The half-life of T1/2 = 6.02 hours has been used in calculating these correction factors. 

Example: If the net activity measured at 30 hours was 15.6 mCi, the calculated activities for 6 and 48 hours would be 

15.6 mCi × 15.9 = 248 mCi and 15.6 mCi × 0.126 = 1.97 mCi, respectively. 
L–3 

1 4.1.5 Plot both the measured net activity and the calculated activity 

2 versus time. 

3 4.1.6 On the graph, the measured net activity plotted should be within plus or 

4 minus 5 percent of the calculated activity if the instrument is linear and 

5 functioning properly. If variations greater than 5 percent are noted, adjust 

6 the instrument, have it repaired, or use arithmetic correction factors to 

7 correct the readings obtained in daily operations. 

8 4.1.7 If instrument linearity cannot be corrected, for routine assays, it will be 

9 necessary to use either an aliquot of the eluate that can be accurately 

10 measured or the graph constructed in Section 4.1.5 to relate measured 

11 activities to calculated activities. 

12 4.2 Shield Method: If a set of “sleeves” of various thicknesses are used to test for 

13 linearity, it will first be necessary to calibrate them. 

14 4.2.1 Begin the linearity test by assaying the technetium-99m syringe or vial in 

15 the dose calibrator, and subtract background to obtain the net activity in 

16 mCi. Record the date, time to the nearest minute, and net activity. This 

17 first assay should be done in the morning at a regular time. After making 

18 the first assay, the sleeves can be calibrated as follows. (Steps in 

19 Sections 4.2.2 through 4.2.4 must be completed within 6 minutes.) 

20 4.2.2 Put the base and sleeve 1 in the dose calibrator with the vial. Record the 

21 sleeve number and indicated activity. 

22 4.2.3 Remove sleeve 1 and put in sleeve 2. Record the sleeve number and 

23 indicated activity. 

24 4.2.4 Continue for all sleeves. 

25 4.2.5 Complete the following decay-method linearity test steps: 

26 4.2.5.1 Repeat the assay at about noon, and again at about 4:00 p.m. 

27 Continue on subsequent days until the assayed activity is less 

28 than 30 microcuries. For dose calibrators on which the range 

29 is selected with a switch, select the range normally used for 

30 the measurement. 

31 4.2.5.2 Convert the time and date information recorded to hours 

32 elapsed since the first assay. 

33 4.2.5.3 On a sheet of semilog graph paper, label the logarithmic 

34 vertical axis in mCi and label the linear horizontal axis in hours 

35 elapsed. At the top of the graph, note the date and the 

36 manufacturer, model number, and serial number of the dose 

37 calibrator. Plot the data. 
L–4 

1 4.2.5.4 Draw a “best fit” straight line through the data points. For the 

2 point farthest from the line, calculate its deviation from the 

3 value on the line. (A-observed - A-line)/(A-line) = deviation 

4 4.2.5.5 If the worst deviation is more than plus or minus 0.05, the dose 

5 calibrator should be repaired or replaced. If this cannot be 

6 done, it will be necessary to make a correction table or graph 

7 that will allow conversion from activity indicated by the dose 

8 calibrator to “true activity.” 

9 4.2.6 From the graph made in Section 4.2.5.3, find the decay time associated 

10 with the activity indicated with sleeve 1 in place. This is the “equivalent 

11 decay time” for sleeve 1. Record that time with the data recorded in 

12 Section 4.2.2. 

13 4.2.7 Find the decay time associated with the activity indicated with sleeve 2 in 

14 place. This is the “equivalent decay time” for sleeve 2. Record that time 

15 with the data recorded in Section 4.2.3. 

16 4.2.8 Continue for all sleeves. 

17 4.2.9 The table of sleeve numbers and equivalent decay times constitutes the 

18 calibration of the sleeve set. 

19 The sleeve set may now be used to test dose calibrators for linearity. 

20 4.2.10 Assay the technetium-99m syringe or vial in the dose calibrator, and 

21 subtract background to obtain the net activity in mCi. Record the 

22 net activity. 

23 4.2.11 Steps in Section 4.2.12 through 4.2.14 below must be completed within 

24 6 minutes. 

25 4.2.12 Put the base and sleeve 1 in the dose calibrator with the vial. Record the 

26 sleeve number and indicated activity. 

27 4.2.13 Remove sleeve 1 and put in sleeve 2. Record the sleeve number and 

28 indicated activity. 

29 4.2.14 Continue for all sleeves. 

30 4.2.15 On a sheet of semilog graph paper, label the logarithmic vertical axis in 

31 mCi, and label the linear horizontal axis in hours elapsed. At the top of 

32 the graph, note the date and the model number and serial number of the 

33 dose calibrator.

34 4.2.16 Plot the data using the equivalent decay time associated with each 

35 sleeve. 
L–5 

1 4.2.17 Draw a “best fit” straight line through the data points. For the point 

2 farthest from the line, calculate its deviation from the value on the line. 

3 (A-observed - A-line)/(A-line) = deviation. 

4 4.2.18 If the worst deviation is more than plus or minus 0.05, the dose calibrator 

5 should be repaired or adjusted. If this cannot be done, it will be 

6 necessary to make a correction table or graph that will allow conversion 

7 from activity indicated by the dose calibrator to “true activity.”

8 5. Geometry independence means that the indicated activity does not change with volume 

9 or configuration. The test for geometry independence should be conducted using 

10 syringes and vials that are representative of the entire range of size, shape, and 

11 constructions normally used for injections and a vial similar in size, shape, and 

12 construction to the radiopharmaceutical kit vials normally used. The following example 

13 assumes that injections are done with 3-cc plastic syringes, that radiopharmaceutical kits 

14 are made in 30-cc glass vials, and that the predetermined safety margin is plus or minus 

15 5 percent. 

16 5.1 In a small beaker or vial, mix 2 cc of a solution of technetium-99m with an activity 

17 concentration between 1 and 10 mCi/ml. Set out a second small beaker or vial 

18 with nonradioactive saline. Tap water may be used. 

19 5.2 Draw 0.5 cc of the technetium-99m solution into the syringe and assay it. Record 

20 the volume and mCi. 

21 5.3 Remove the syringe from the calibrator, draw an additional 0.5 cc of 

22 nonradioactive saline or tap water, and assay again. Record the volume and 

23 mCi indicated. 

24 5.4 Repeat the process until a volume of 2.0 cc has been assayed. The entire 

25 process must be completed within 10 minutes. 

26 5.5 Select as a standard the volume closest to that normally used for injections. For 

27 all other volumes, divide the standard mCi by the mCi indicated for each volume. 

28 The quotient is a volume correction factor. Alternatively, graph the data and 

29 draw horizontal error lines above and below the chosen “standard volume.” 

30 5.6 If any correction factors are greater than 1.05 or less than 0.95, or if any data 

31 points lie outside the error lines, it will be necessary to make a correction table or 

32 graph that will allow a conversion from “indicated activity” to “true activity.” If this 

33 is necessary, be sure to label the table or graph “syringe geometry dependence,” 

34 and note the date of the test and the model and serial number of the calibrator. 

35 5.7 To test the geometry dependence for a 30-cc glass vial, draw 1.0 cc of the 

36 technetium-99m solution into a syringe and then inject it into the vial. Assay the 

37 vial. Record the volume and mCi indicated. 

38 5.8 Remove the vial from the calibrator and, using a clean syringe, inject 2.0 cc of 

39 nonradioactive saline or tap water, and assay again. Record the volume and 

40 mCi indicated. 
L–6 

1 5.9 Repeat the process until a volume of 19.0 cc has been assayed. The entire 

2 process must be completed within 10 minutes. 

3 5.10 Select as a standard the volume closest to that normally used for mixing 

4 radiopharmaceutical kits. For all other volumes, divide the standard mCi by the 

5 mCi indicated for each volume. The quotient is a volume correction factor. 

6 Alternatively, the data may be graphed, with horizontal 5 percent error lines 

7 drawn above and below the chosen “standard volume.” 

8 5.11 If any correction factors are greater than 1.05, or less than 0.95, or if any data 

9 points lie outside the 5 percent error lines, it will be necessary to make a 

10 correction table or graph that will allow conversion from “indicated activity” to 

11 “true activity.” If this is necessary, be sure to label the table or graph “vial 

12 geometry dependence,” and note the date of the test and the model number and 

13 serial number of the calibrator. 

14 6. Accuracy means that, for a given calibrated reference source, the indicated mCi value is 

15 equal to the mCi value determined by the NIST or by the supplier who has compared 

16 that source to a source that was calibrated by NIST. Certified sources are available from 

17 NIST and from many radionuclide suppliers. At least two sources with different principal 

18 photon energies (such as cobalt-57, cobalt-60, cesium-137) should be used. One 

19 source should have a principal photon energy between 100 keV and 500 keV. If a 

20 radium-226 source is used, it should be at least 10 microcuries; other sources should be 

21 at least 50 microcuries. Consider using at least one reference source with an activity 

22 that is within the range of activities normally assayed. 

23 6.1 Assay a calibrated reference source at the appropriate setting (e.g., use the 

24 cobalt-57 setting to assay cobalt-57) and then remove the source and measure 

25 background. Subtract background from the indicated activity to obtain the net 

26 activity. Record this measurement. Repeat for a total of 3 determinations. 

27 6.2 Average the 3 determinations. The average value should be within the 

28 predetermined safety margin, which in this example is 5 percent of the certified 

29 activity of the reference source, mathematically corrected for decay. 

30 6.3 Repeat the procedure for other calibrated reference sources. 

31 6.4 If the average value does not agree, within 5 percent, with the certified value of 

32 the reference source, the dose calibrator may need to be repaired or adjusted. 

33 The dose calibrator should be repaired or replaced if the error exceeds 10 

34 percent. 

35 6.5 At the same time the accuracy test is performed, assay the source that will be 

36 used for the daily constancy test (it need not be a certified reference source) on 

37 all commonly used radionuclide settings. Record the settings and indicated mCi 

38 values with the accuracy data. 

39 7. The individual performing the tests will sign or initial and date the records of all 

40 geometry, linearity, and accuracy tests.
1 APPENDIX M 

2 MATERIAL RECEIPT AND ACCOUNTABILITY

M–1 

1 Material Receipt and Accountability 

2 Prior to any transfer from the license, the licensee must verify that the recipient is authorized to 

3 receive the licensed material, as required by Title 10 of the Code of Federal Regulations

4 (10 CFR) 30.41, 40.51 and 70.42. 

5 The regulations in 10 CFR 30.51, 40.61, 70.51 and 10 CFR Part 74 require the licensee to 

6 maintain records of receipt, transfer, and disposal of all licensed materials. 

7 Sample Model Procedure for Ordering and Receiving Radioactive Material 

8  The Radiation Safety Officer (RSO) will approve or place all orders for radioactive 

9 material and will ensure that the requested material, quantities, manufacturer, and model 

10 are authorized by the license and that the possession limits are not exceeded. 

11  Instruct carriers to deliver radioactive packages directly to the designated receiving area. 

12 Sample Instructions to Personnel Involved in Material Receipt 

13 Shipping and Receiving Personnel 

14 During normal working hours, within 3 hours of receipt of any package of licensed material, 

15 each package must be visually inspected for any signs of shipping damage, such as crushed or 

16 punctured containers or signs of dampness. Any suspected damage must be reported to the 

17 RSO immediately. Do not touch any package suspected of leaking. Request the person 

18 delivering the package, if still on site, to remain until monitored by the RSO. 

19 Outside of normal working hours (e.g., nights, weekends, and holidays), deliveries may be 

20 made to a designated, secured storage area. These packages must be checked for 

21 contamination and external radiation levels within 3 hours after personnel arrive at the facility. 

22 They will not be allowed to remain in the designated storage area any longer than necessary, as 

23 they may be a source of exposure for personnel. 

24 Sample Procedure for Safely Opening Packages Containing Licensed Materials 

25 For packages received under the specific license, authorized individuals will implement 

26 procedures for opening each package, as follows: 

27  Wear gloves to prevent hand contamination. 

28  Visually inspect the package for any sign of damage (e.g., crushed, punctured, leakage). 

29 If damage is noted, stop and notify the RSO. 

30  Check U.S. Department of Transportation (DOT) White I, Yellow II, or Yellow III label or 

31 packing slip for activity of contents, to ensure that the shipment does not exceed license 

32 possession limits. 

33  Open the outer package (following supplier’s directions if provided) and remove packing 

34 slip. Open inner package to verify contents, comparing requisition, packing slip, and 

35 label on the container. Check integrity of the final source container (e.g., inspecting for 

36 breakage of seals or vials, loss of liquid, discoloration of packaging material, high count 
M–2 

1 rate on wipe). Again check that the shipment does not exceed license possession limits. 

2 If anything other than the expected observation is identified, stop and notify the RSO. 

3  Survey the packing material and packages for contamination before discarding. If 

4 contamination is found, treat as radioactive waste. If no contamination is found, 

5 obliterate the radiation labels before discarding in the regular trash. 

6  Maintain records of receipt, package survey, and wipe test results. 

7  Notify the final delivery carrier and the U.S. Nuclear Regulatory Commission Operations 

8 Center, 301-816-5100, by telephone when removable radioactive surface contamination 

9 exceeds the limits of 10 CFR 71.87(i), or external radiation levels exceed the limits of 

10 10 CFR 71.47. 

11  If applicable, comply with the National Source Tracking System reporting requirement as 

12 described in 10 CFR 20.2207, “Reports of Transactions Involving Nationally Tracked 

13 Sources.”
1 APPENDIX N 

2 GENERAL TOPICS FOR SAFE USE OF RADIONUCLIDES AND MODEL 

3 EMERGENCY PROCEDURES

N–1 

1 General Topics for Safe Use of Radionuclides and Model 

2 Emergency Procedures 

3 General Topics for Safe Use of Radionuclides 

4 Each licensee using radioactive material will establish general rules for the safe use of the 

5 material so that workers know what is required. Typical instructions should include 

6  Wear a laboratory coat or other protective clothing at all times when working with 

7 radioactive materials. 

8  Use syringe shields and vial shields when preparing and handling radioactive drugs. 

9  Measure all radiopharmaceuticals before transfer. 

10  Measure the molybdenum-99 content of each generator elution, and do not transfer 

11 those radiopharmaceuticals for human medical use that will contain more than 

12 0.15 microcuries of molybdenum-99 per mCi of technetium-99m at the time 

13 of administration. 

14  Wear disposable gloves at all times when handling radioactive materials, and change 

15 gloves frequently to minimize the spread of contamination. 

16  Before leaving the hot lab, monitor hands, shoes, and clothing for contamination in a 

17 low-background area, allowing sufficient time for instrument response. 

18  Do not eat, drink, smoke, or apply cosmetics in any area where licensed material is 

19 stored or used. 

20  Do not store food, drink, or personal effects in areas where licensed material is stored or 

21 used (see Figure N-1). 

22  Survey for contamination personal items brought into the restricted area (e.g., radios, 

23 music players, cell phones, notepads, books) before they are removed from the area. 

24  Clearly label “Not for personal consumption” on food and beverages used in preparation 

25 of radiopharmaceuticals if it is stored with radioactive materials. 

26  Wear personnel monitoring devices, if required, at all times while in areas where 

27 licensed materials are used or stored. 

28  Dispose of radioactive waste only in designated, labeled, and properly shielded 

29 receptacles. 

30  Never pipette by mouth. 

31  Store radioactive solutions in clearly labeled containers. 

32  Secure all licensed material when it is not under the constant surveillance and 

33 immediate control of the user(s). 
N–2 

Figure N–1. Storage of Food and Drink 

 Food or drink for personal consumption should not be stored in refrigerators with 

radionuclides. 

1 Model Procedures for Handling Millicurie Quantities of Radioiodine 

2 Because of the potential for significant intakes due to volatility and accidental ingestion, and the 

3 potential for skin exposures (shallow-dose equivalent) from contamination, licensees will 

4 establish specific procedures for the containment and handling of mCi quantities of radioiodine, 

5 most commonly iodine-131. The following guidance is the minimum that should be considered if 

6 the applicant intends to manipulate radioiodine. 

7  Manipulation of radioiodine (e.g., handling or compounding capsules, performing 

8 radioiodination, dispensing from bulk solution) will be conducted in an isolated area 

9 within the main hot lab of the pharmacy. This will aid in maintaining exposures as low as 

10 is reasonably achievable (ALARA) and provide a means to isolate the area in the event 

11 of a spill. 

12  Radioiodine handling will only be performed inside a glovebox or fume hood that has a 

13 face velocity of 100 to 150 linear feet per minute. The ventilation for gloveboxes and 

14 fume hoods will be checked at least once every 6 months to ensure adequate airflow 

15 and confirm negative pressure with respect to the area around the glovebox or fume 

16 hood. Exhaust stacks for gloveboxes and fume hoods used for handling radioiodine will 

17 not be located near ventilation intakes to minimize the likelihood of recirculation to the 

18 pharmacy or to other tenants in a shared building. 

19  Gloveboxes and fume hoods must include appropriate filters (activated charcoal) to 

20 minimize effluents from radioiodine handling. 

21  Filters must be installed and used in accordance with the manufacturer’s specifications 

22 (e.g., adequate air flow to ensure adequate residence time). 

Food/Drink Storage is

Prohibited

RPh19a.ppt

082898
N–3 

1  Check filters at installation and periodically, based on use, but not less than once per 

2 calendar quarter, to ensure continued efficiency. 

3  Air flow through fume hoods and gloveboxes will be confirmed before each use. 

4  Magna-helic sensors, if used, will be checked before each use of the glovebox or fume 

5 hood, to ensure minimum flow across the filter. 

6  Locate absorbent materials and dry chemical buffers, for use in the event of a spill, near 

7 the area where mCi quantities of radioiodine are handled. 

8  Additional protective clothing will be used when handling mCi quantities of radioiodine. 

9 Personnel will be double-gloved and use shoulder-length sleeve guards. The gloves 

10 and glove seals on gloveboxes will be checked periodically and replaced when needed. 

11  Consider all personnel handling greater than 500 mCi of iodine-131 per year for 

12 inclusion in a bioassay program. This is the threshold below which intakes over 1 

13 percent of the annual limit on intake (ALI) are not likely, and assumes no containment. 

14 When used in a properly operating fume hood, the threshold for consideration of the 

15 need for bioassay rises to 5 Ci of iodine-131. If used in a properly operating glovebox, 

16 with properly sealed glove ports and well-maintained gloves, the threshold rises to 50 Ci 

17 of iodine-131 handled by one person per year. Pharmacies using gloveboxes that do 

18 not have sealed glove ports may not use the threshold indicated for that equipment, but 

19 may use the threshold for properly maintained fume hoods. 

20 Bioassay Monitoring 

21 Frequency of Required Bioassay Measurements 

22 Determining the appropriate frequency of routine bioassay measurements depends upon the 

23 exposure potential and the physical and chemical characteristics of the radioactive material and 

24 the route of entry to the body. Consider the following elements: 

25  potential exposure of the individual 

26  retention and excretion characteristics of the radionuclide 

27  sensitivity of the measurement technique 

28  acceptable uncertainty in the estimate of intake and committed dose equivalent 

29 Bioassay measurements used for demonstrating compliance with the occupational dose limits 

30 should be conducted often enough to identify and quantify potential exposures and resultant 

31 intakes that, during any year, are likely to collectively exceed 0.1 times the ALI. The 10 percent 

32 ALI criterion is consistent with 10 CFR 20.1502(b), which requires licensees to monitor intakes 

33 and assess occupational doses for exposed individuals who are likely to exceed 10 percent of 

34 the applicable limit (i.e., intakes likely to exceed 0.1 ALI for adults). 

35 Separate categories of bioassay measurements, routine measurements, and nonroutine 

36 (emergency) measurements further determine the frequency and scope of measurements.
N–4 

1 Routine Bioassay Measurements 

2 Routine bioassay measurements include baseline measurements, periodic measurements, and 

3 termination measurements. These measurements should be conducted to confirm that 

4 appropriate controls exist and to assess dose. 

5 An individual’s baseline measurement of radioactive material within the body should be 

6 conducted before beginning work that involves exposure to radiation or radioactive materials for 

7 which monitoring is required. 

8 In addition to the baseline measurements, periodic bioassay measurements should be 

9 performed. The frequency of periodic measurements should be based on the likelihood of 

10 significant exposure of the individual. In determining the worker’s likely exposure, consider such 

11 information as the worker’s access, work practices, measured levels of airborne radioactive 

12 material, and exposure time. Periodic measurements should be made when the cumulative 

13 exposure to airborne radioactivity (since the most recent bioassay measurement) is greater than 

14 0.02 ALI [40 derived air concentration (DAC) hours]. Noble gases and airborne particulates with 

15 a radioactive half-life of less than 2 hours should be excluded from the evaluation, since 

16 external exposure generally controls these radionuclides. 

17 When an individual is no longer subject to the bioassay program because of change in 

18 employment status, termination bioassay measurements should be made, when practicable, to 

19 ensure that any unknown intakes are quantified. 

20 Nonroutine (Emergency) Bioassay Monitoring 

21 Because of uncertainty in the time of intakes and the absence of other data related to the 

22 exposure (e.g., physical and chemical forms, exposure duration), correlating positive results to 

23 actual intakes for routine measurements can sometimes be difficult. Abnormal and inadvertent 

24 intakes from situations such as inadequate engineering controls, inadvertent ingestion, 

25 contamination of a wound, or skin absorption, should be evaluated on a case-by-case basis. 

26 When determining whether potential intakes should be evaluated, consider the following 

27 circumstances: 

28  presence of unusually high levels of facial and/or nasal contamination 

29  operational events with a reasonable likelihood that a worker was exposed to unknown 

30 quantities of airborne radioactive material (e.g., loss of system or container integrity) 

31  known or suspected incidents of a worker ingesting radioactive material 

32  incidents that result in contamination of wounds or other skin absorption 

33 Model Procedures for Responding to Events 

34 Thresholds for Defining Minor Contamination Events, Minor Spills, and 

35 Major Spills 

36 Licensees will establish clearly delineated thresholds for describing these types of events. 

37 Licensees should establish a graded response to emergencies, incorporating increasing 

38 formality of a response based on the potential risks posed by the events. No emergency 
N–5 

1 procedure can anticipate every likely event; therefore, flexibility and judgment must be 

2 incorporated into such procedures. If licensee staff members are not sure of the proper or 

3 expected response to any event, they will be instructed to immediately cease further action, 

4 control access to the area, contact the RSO, and wait for instructions. 

5 Minor Contamination Events 

6 Minor contamination events are those events typically identified through routine surveys that 

7 involve removable contamination levels greater than the licensee’s action limit, but less than ten 

8 times the licensee’s action limit. These events can be easily decontaminated without the need 

9 for strict adherence to a step-by-step procedure. Such events require judgment on the part of 

10 the individuals responding to determine the scope and extent of the contamination and to 

11 assess their ability to respond effectively. In order to prevent the spread of contamination, 

12 coworkers will be notified if decontamination of the area will be delayed. The RSO will be 

13 notified promptly of such events, either before, or immediately after, cleanup of the area. 

14 Isolated minor contamination events may not require a formal root cause evaluation or 

15 extensive corrective action determinations; however, the occurrence of several events in the 

16 same location, involving the same individual, or during similar processes, may warrant such 

17 in-depth evaluations and determinations. 

18 Minor Spills 

19 Minor spills are those events typically identified at the time they occur (e.g., events involving a 

20 dropped syringe or vial containing radioactive material resulting in the release (spill) of 

21 radioactive material requiring a more formal adherence to a step-by-step procedure). Such 

22 events will usually involve mCi quantities of material and have a potential for exposures to 

23 personnel or the public if not properly controlled and decontaminated. The upper limit for 

24 defining minor spills will not be more than 5 times the lowest ALI of the material involved in the 

25 spill. Such a limit would include the following quantities of radioactive material: 

26 (1) Up to 400 mCi of technetium-99m 

27 (2) Up to 150 microcuries of iodine-131 

28 (3) Up to 250 mCi of fluorine-18 

29 (4) Up to 100 mCi of thallium-201 

30 (5) Up to 10 mCi of samarium-153 

31 Minor spills may warrant root cause evaluations and corrective action determinations, 

32 depending on the circumstances. The RSO will be notified immediately of such events so that 

33 decontamination procedures can be monitored. Minor spills involving quantities of radioactive 

34 material near the upper threshold may require more than one person to respond to assist in the 

35 cleanup, perform confirmation surveys, or monitor materials and personnel exiting the area. 

36 Major Spills 

37 Any spill involving a quantity of radioactive material in excess of the quantity defined for a minor 

38 spill is considered a major spill. Such spills have a greater potential for exposures to workers 

39 and the public, including the possibility of overexposure, if not properly contained. Individuals 

40 should never attempt to clean a major spill by themselves, or without the personal supervision 

41 and direction of the RSO. Major spills must be reported to the U.S. Nuclear Regulatory 

42 Commission (NRC), if required by the requirements in 10 CFR 30.50. Major spills may also 

43 require evaluations of intakes and skin doses, if personnel contamination is identified, as well as 
N–6 

1 root cause evaluations and corrective action determinations. Qualified assistance will be sought 

2 immediately for those major spills that are beyond the licensee’s capability to address. 

3 General Safety Procedures to Handle Spills 

4  The name and telephone number of the RSO or an alternate person(s) will be posted 

5 conspicuously in areas of use, so that they are readily available to workers in case of 

6 emergencies. Licensees will have emergency equipment readily available for handling 

7 spills. Spill response materials should include the following: 

8 — disposable gloves 

9 — housekeeping gloves 

10 — disposable lab coats 

11 — disposable shoe covers 

12 — roll of absorbent paper with plastic backing 

13 — masking tape 

14 — plastic trash bags with twist ties 

15 — “Radioactive Material” labeling tape 

16 — marking pen 

17 — prestrung “Radioactive Material” labeling tags 

18 — box of wipes 

19 — instructions for “Emergency Procedures” 

20 — clipboard with a copy of the Radioactive Spill Report Form for the facility 

21 — cleaning agent 

22 — pen or pencil 

23 Minor Contaminations and Spills of Liquids and Solids 

24  Instructions to workers 

25 — These instructions apply to minor contamination events (less than 10 times the 

26 licensee’s action limit) and minor spills of radioactive material. The response to 

27 each is similar; however, the response to minor contamination events need not 

28 be as formal as the response to spills involving mCi quantities of radioactive 

29 material. 

30 — Notify persons in the area that a spill has occurred. 

31 — Prevent the spread of contamination by covering the spill with absorbent paper. 

32 Paper will be dampened if solids are spilled. 

33 — Clean up the spill by wiping from the perimeter of the spill to the center of the 

34 spill, wearing disposable gloves and using absorbent paper. 

35 — Carefully fold the absorbent paper with the clean side out and place in a plastic 

36 bag for transfer to a radioactive waste container. Put contaminated gloves and 

37 any other contaminated disposable material in the bag. 
N–7 

1 — Resurvey the area. Check the area around the spill for contamination. Also 

2 check hands, clothing, and shoes for contamination. 

3 — Report the incident to the RSO promptly. 

4  Reminders to RSO 

5 — Follow up on the decontamination activities and document the results. 

6 — As appropriate, determine cause and corrective actions needed; consider 

7 bioassays if licensed material may have been ingested or inhaled. 

8 — If necessary, notify the NRC. 

9 Major Spills of Liquids and Solids 

10  Instructions to workers 

11 — Clear the area. If appropriate, survey all persons not involved in the spill and 

12 vacate the room. 

13 — Prevent the spread of contamination by covering the spill with absorbent paper 

14 (paper will be dampened if solids are spilled), but do not attempt to clean it up. 

15 To prevent the spread of contamination, limit the movement of all personnel who 

16 may be contaminated. 

17 — Shield the source only if it can be done without further contamination or 

18 significant increase in radiation exposure. 

19 — Close the room and secure the area to prevent entry. Post a sign to warn 

20 anyone trying to enter that a spill of radioactive material has occurred. 

21 — Notify the RSO immediately. 

22 — Survey all personnel who could possibly have been contaminated. 

23 Decontaminate personnel by removing contaminated clothing and flushing 

24 contaminated skin with lukewarm water and then washing with a mild soap. 

25 — Allow no one to return to work in the area unless approved by the RSO. 

26 — Follow the instructions of the RSO (e.g., with regard to decontamination 

27 techniques, surveys, submission of bioassay samples, requested 

28 documentation). 

29  Reminders to RSO 

30 — Confirm decontamination of personnel. If decontamination of personnel was not 

31 fully successful, consider inducing perspiration by covering the area with plastic. 

32 Then wash the affected area again to remove any contamination that was 

33 released by the perspiration. 
N–8 

1 — Skin contamination must be evaluated to determine potential exposures. 

2 Beta-emitting radionuclides have a high potential for resulting in shallow-dose 

3 exposures in excess of regulatory limits from small (microcurie) quantities of 

4 contamination. 

5 — Supervise decontamination activities and document the results. Include location 

6 and results of surveys and decontamination results. 

7 — Determine root cause and needed corrective actions; consider need for 

8 bioassays if licensed material may have been ingested, inhaled, or absorbed. 

9 — If necessary, notify the NRC. 

10 Minor Fires 

11  Instructions to workers 

12 — If possible, immediately attempt to put out the fire by approved methods (e.g., fire 

13 extinguisher) if other fire hazards or radiation hazards are not present. 

14 — Notify all persons present to vacate the area and have one individual immediately 

15 call the RSO and fire department or 911 (as instructed by the RSO). 

16 — Once the fire is out, isolate the area to prevent the spread of possible 

17 contamination. 

18 — Ensure injured personnel receive medical attention. 

19 — Survey all persons involved in fighting the fire for possible contamination. 

20 — Decontaminate personnel by removing contaminated clothing and flushing 

21 contaminated skin with lukewarm water, then washing with a mild soap. 

22 — In consultation with the RSO, determine a plan of decontamination and the types 

23 of protective devices and survey equipment that will be necessary to 

24 decontaminate the area. 

25 — Allow no one to return to work in the area unless approved by the RSO. 

26 — Follow the instructions of the RSO (e.g., with regard to decontamination 

27 techniques, surveys, submission of bioassay samples, requested 

28 documentation). 

29  Reminders to RSO 

30 — Notify emergency medical personnel of any injured individuals who may be 

31 contaminated. Provide radiation safety assistance (e.g., monitoring) as needed 

32 or requested. 

33 — Supervise decontamination activities at the facility. 
N–9 

1 — If decontamination of personnel was not fully successful, consider inducing 

2 perspiration by covering the area with plastic. Then wash the affected area again 

3 to remove any contamination that was released by the perspiration. 

4 — Consult with fire safety officials to ensure that there is no likelihood of fire 

5 restarting and that it is safe to re-enter the building. 

6 — Determine cause and needed corrective actions; consider need for bioassays if 

7 licensed material may have been ingested or inhaled. Document the incident. 

8 — If necessary, notify the NRC. 

9 Fires, Explosions, or Major Emergencies 

10  Instructions to workers 

11 — Notify all persons in the area to leave immediately. 

12 — Notify the fire department or 911. 

13 — Notify the RSO and other facility safety personnel. 

14 — Ensure injured personnel receive medical attention. 

15 — Upon arrival of firefighters, inform them where radioactive materials are stored or 

16 where radionuclides were being used; inform them of the present location of the 

17 licensed material and the best possible entrance route to the radiation area, as 

18 well as any precautions to avoid exposure or risk of creating radioactive 

19 contamination, such as by use of high-pressure water. 

20 — Allow no one to return to work in the area unless approved by the RSO. 

21 — Follow the instructions of the RSO (e.g., with regard to decontamination 

22 techniques, surveys, submission of bioassay samples, requested 

23 documentation). 

24  Reminders to RSO 

25 — Notify emergency medical personnel of any injured individuals who may be 

26 contaminated. Provide radiation safety assistance (e.g., monitoring) as needed 

27 or requested. 

28 — Coordinate activities with local fire department or other emergency personnel. 

29 — Consult with the firefighting personnel or other emergency personnel and set up 

30 a controlled area where personnel can be surveyed for contamination of their 

31 protective clothing and equipment after the fire is extinguished. 

32 — Once the fire is extinguished, provide assistance to firefighters or other 

33 emergency personnel who may need to re-enter restricted areas to determine the 

34 extent of the damage to the licensed material use and storage areas. To the 
N–10 

1 extent practical, assist firefighters and emergency personnel in maintaining their 

2 exposures ALARA if the fire resulted in a significant release of radioactive 

3 material or loss of shielding capability, such that excessive radiation levels 

4 (greater than 100 mrem/hour) are created. 

5 — Perform thorough contamination surveys of firefighters and emergency personnel 

6 and their equipment before they leave the controlled area, and decontaminate if 

7 necessary. 

8 — Supervise decontamination activities. 

9 — Consider bioassays if licensed material may have been ingested or inhaled. 

10 Document the incident. 

11 — If necessary, notify the NRC. 

12 Copies of emergency procedures should be provided to all users. A current copy of the 

13 emergency procedures should be posted in each area where radioactive material is used. 
1 APPENDIX O 

2 RADIATION SURVEY GUIDELINES

O–1 

1 Radiation Survey Guidelines 

2 Radiological surveys in a radiopharmacy include measurements of ambient radiation levels, 

3 surface contamination levels, and concentrations of radiation in effluents. Surveys are 

4 necessary in order to demonstrate compliance with regulatory requirements, characterize and 

5 evaluate changes in workplace radiological conditions, ensure proper posting of radiological 

6 conditions, plan work activities, evaluate the effectiveness of administrative and engineering 

7 controls (i.e., shielding), evaluate trends, reduce personnel exposure, and evaluate effluent 

8 releases and their impact on the public or environment. Licensees should develop, implement, 

9 and maintain written procedures for the performance of surveys and monitoring that meet the 

10 regulatory requirements. Surveys should be performed to assess radiation and contamination 

11 levels in restricted and unrestricted areas. The licensee’s written procedures for a survey 

12 program should include action levels, frequencies, and records maintenance of those surveys. 

13 Individuals performing radiation surveys should be appropriately trained and qualified to conduct 

14 and document surveys and identify unexpected or abnormal conditions requiring action to 

15 reduce radiation levels or contamination levels. Instruments used for quantitative radiation 

16 measurements must be calibrated periodically for the radiation measured. Licensees must 

17 possess calibrated and operable radiation instruments to detect and measure radiation levels, 

18 radioactive contamination, and radioactivity, as applicable. The licensee should possess 

19 radiation monitoring instruments sufficiently sensitive to measure the type and energy of 

20 radiation used. 

21 Radiation Level Surveys 

22 Radiation level surveys are used to monitor the workplace and reduce radiation exposure and 

23 are important for maintaining radiation doses as low as is reasonably achievable (ALARA). 

24  At a minimum, dose-rate surveys should be performed in locations where workers are 

25 exposed to radiation levels that might result in radiation doses in excess of 10 percent of the 

26 occupational dose limits. 

27  At a minimum, dose-rate surveys should be performed in locations where members of the 

28 public could receive TEDE of 1 mSv [100 mrem] in a year, or the dose in any unrestricted 

29 area from external sources could exceed 0.02 mSv [2 mrem] in any 1 hour. 

30  Dose-rate surveys should be performed in a manner and frequency that is representative of 

31 the use of radioactive materials. As appropriate, radiation surveys should be performed 

32 before, during, and after activities involving radioactive materials. At a minimum, radiation 

33 surveys should be conducted daily in areas of radioactive material use, where exposures to 

34 workers could reasonably occur (e.g., generator storage/elution and dose preparation 

35 stations). Other areas, where radiological conditions are not expected to change 

36 appreciably from day to day, should be surveyed weekly (e.g., radioactive waste storage 

37 areas). 

38  Dose-rate surveys should be performed whenever changes in the facility layout/design 

39 occur, or whenever licensed activities change and could result in changes to the radiological 

40 conditions. 

41  Dose-rate surveys should be performed to demonstrate compliance with regulatory 

42 requirements, characterize and evaluate changes in workplace radiological conditions, 
O–2 

1 ensure proper posting of radiological conditions, plan work activities, evaluate the 

2 effectiveness of administrative and engineering controls (e.g. shielding), evaluate trends, 

3 reduce personnel exposure, and evaluate doses to the general public. 

4 Surface Contamination Surveys 

5 Licensees’ contamination surveys should be sufficient to identify areas of contamination that 

6 might result in unacceptable levels of exposure to workers or to the public. Contamination 

7 surveys can provide insight into whether work practices and engineering controls are effective in 

8 handling radioactive materials. Radioactive contamination, if undetected, can be spread 

9 throughout a facility, can be spread to personnel, and can be spread into unrestricted or public 

10 areas, including the environment. Exposure of individuals to contamination can result in 

11 external as well as potential internal radiation dose through inhalation or ingestion of the 

12 material. 

13 Combined removable and fixed contamination should be surveyed using appropriate radiation 

14 detection equipment. Removable contamination can be detected and measured through wipe 

15 surveys, which should be analyzed using an appropriate counting instrument. A standardized 

16 method for wipe testing of a relatively uniform area should be used to aid in comparing 

17 contamination at different times and places. A wipe taken from an area of approximately 

100 cm2 18 is acceptable to indicate levels of removable contamination. Fixed contamination may 

19 be measured directly at the surface of the contamination with the appropriate instrument 

20 detector held at close proximity to the surface without direct contact. Instruments used for 

21 contamination surveys should be operable and calibrated and be appropriate to detect or 

22 measure the type of radiation. 

23 Contamination surveys should be performed 

24  to evaluate radioactive contamination that could be present on surfaces of floors, walls, 

25 laboratory furniture, or equipment 

26  after any spill or contamination event 

27  to evaluate the immediate work area at the end of each day when licensed material is 

28 used 

29  to evaluate potential personnel contamination each time an individual exits the restricted 

30 area and to evaluate the contamination of any items being removed from the restricted 

31 area 

32  in unrestricted areas at frequencies consistent with the types and quantities of materials 

33 in use 

34  in areas adjacent to restricted areas and in all areas through which licensed materials 

35 are transferred and temporarily stored before shipment 

36 All areas where radioactive materials are eluted, prepared, assayed, dispensed, or packaged for 

37 transport should be surveyed daily. All other areas where radioactive materials are used or 

38 stored should be surveyed weekly or as necessary to evaluate any potential spills or 

39 contamination events. 
O–3 

1 Licensees should establish action levels for the detection of contamination. Typically, licensees 

2 establish action levels that are twice the known background radiation level. Contamination 

3 found in unrestricted areas that exceeds the action levels should be immediately 

4 decontaminated to background levels. When decontamination efforts fail to achieve 

5 background levels, the licensee should take other actions to maintain radiation doses ALARA. 

6 These measures can include the use of shielding or other materials to cover the contaminated 

7 area, or restricting access to the contaminated area to allow for radioactive decay. 

8 Survey Record Requirements 

9 Each survey report should include the following: 

10  diagram of the area identifying specific locations surveyed (see Figure 8-2 of this 

11 NUREG) 

12  ambient radiation levels with appropriate units 

13  contamination levels with appropriate units 

14  make, model, and serial number of instruments used 

15  background levels 

16  name of the person making the evaluation and recording the results and date 

17  corrective actions taken for elevated levels identified and results of resurveys 

18 Licensees should record contamination levels observed and procedures followed for incidents 

19 involving contamination of individuals. The record should include names of individuals involved, 

20 description of work activities, calculated dose, probable causes (including root causes), steps 

21 taken to reduce recurrence of contamination, times and dates, and surveyor’s signature. 

22 Airborne Radioactivity Monitoring 

23 Airborne radioactivity monitoring should be performed in areas where individuals may be 

24 exposed to airborne radiation that could result in doses in excess of 10 percent of the annual 

25 dose limit. Licensees that perform air monitoring should carefully consider their equipment 

26 selection based on the specific activities that are to be monitored. Equipment for airborne 

27 activity monitoring includes air sampling equipment (portable and fixed) as well as continuous 

28 air monitors.

29 Airborne radioactivity monitoring can be used to do the following: 

30  determine the effectiveness of engineering controls 

31  measure airborne radioactive material concentrations in the workplace 

32  estimate worker intakes of radioactive material 

33  determine posting requirements 

34  determine what protective equipment and measures are appropriate 

35  warn of significantly elevated levels of airborne radioactive materials 

36 Air Effluent Release Monitoring 

37 Airborne radioactive effluents should be monitored at the release points (e.g., stack) to provide 

38 accurate measurements to estimate public exposure and to demonstrate compliance with 

39 effluent release criteria. Licensees should verify the performance of effluent monitoring systems 
O–4 

1 by regular calibration of equipment and checks of filtration to ensure effluent monitoring systems 

2 reliability and effectiveness. 

3 RG 4.20, Rev. 1., “Constraint on Releases of Airborne Radioactive Materials to the Environment 

4 for Licensees Other Than Power Reactors,” April 2012, provides guidance on methods 

5 acceptable (calculation or COMPLY code) to the U.S. Nuclear Regulatory Commission (NRC) 

6 for compliance with the constraint on air emissions to the environment. 

7 RG 8.37, “ALARA Levels for Effluents from Materials Facilities,” dated July 1993, provides 

8 guidance on designing an acceptable program for establishing and maintaining ALARA levels 

9 for gaseous and liquid effluents at materials facilities. 

10 Effluent monitoring systems should be designed in accordance with ANSI N13.1-2011, 

11 “Sampling And Monitoring Releases Of Airborne Radioactive Substances From The Stacks And 

12 Ducts Of Nuclear Facilities,” and ANSI N42.18-2004, “Specification and Performance of On-Site 

13 Instrumentation for Continuously Monitoring Radioactivity in Effluents.” 

14 Radioiodine Monitoring 

15 The handling of radioiodine requires additional surveys and monitoring. Such surveys and 

16 monitoring should include 

17  routine surveys of air filters incorporated in fume hoods and gloveboxes to identify when 

18 filters should be exchanged before saturation 

19  routine surveys in the area where radioiodine is handled immediately following each use 

20 to identify elevated radiation and contamination levels 

21  continuous monitoring of the air effluent during radioiodine use 

22 Note: In-line filters should be monitored periodically to determine actual effluents. 

23 Sanitary Sewerage Release Monitoring 

24 The licensee should evaluate the concentrations of radioactive material in water and liquid 

25 effluent that is released to the environment and to the sanitary sewer. The licensee must show 

26 that these releases meet the limits in 10 CFR 20.1301, “Dose limits for individual members of 

27 the public,” and 10 CFR 20.2003, “Disposal by release into sanitary sewerage,” respectively. 

28 References: 

29 RG 4.20, Revision 1., “Constraint on Releases of Airborne Radioactive Materials to the 

30 Environment for Licensees Other Than Power Reactors,” dated April 2012. 

31 RG 8.9, Revision 1, “Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay 

32 Program,” dated July 1993. 

33 RG 8.25, Revision 1, “Air Sampling in the Workplace,” dated June 1992. 

34 RG 8.37, “ALARA Levels for Effluents from Materials Facilities,” dated July 1993. 
O–5 

1 NUREG-1400, “Air Sampling in the Workplace,” dated September 1993. 

2 NUREG/CR-4884, “Interpretation of Bioassay Measurements,” dated July 1987. 

3 ANSI N13.1-2011, “Sampling and Monitoring Releases of Airborne Radioactive Substances 

4 from the Stacks and Ducts of Nuclear Facilities,” dated January 2011. 

5 ANSI N42.18-2004, “Specification and Performance of On-site Instrumentation for Continuously 

6 Monitoring Radioactivity in Effluents,” dated 2004. 

7 ANSI/HPS N13.49-2001, “Performance and Documentation of Radiological Surveys,” dated 

8 June 2001 (Reaffirmed in 2011).

1 APPENDIX P 

2 MODEL PROCEDURE FOR RETURN OF RADIOACTIVE WASTES 

3 FROM CUSTOMERS 

P–1 

1 Model Procedure for Return of Radioactive Wastes from Customers 

2 Procedures for Customers to Return Radioactive Waste to the Radiopharmacy 

3 Return only items that contained or contain radioactive materials supplied by the radiopharmacy 

4 (e.g., pharmacy-supplied syringes and vials and their contents). Most return shipments to 

5 radiopharmacies will qualify as excepted packages of limited quantity, in accordance with Title 

6 49 of the Code of Federal Regulations (49 CFR) 173.421. For those packages containing 

7 radioactive material in excess of the limited quantity, customers will ensure that all applicable 

8 U.S. Department of Transportation (DOT) requirements are met for the packages. These 

9 include, but are not limited to, certification packaging (Type A), package marking and labeling, 

10 and shipping papers. For specific guidance on preparing these types of packages, follow the 

11 in-house procedures for shipping radioactive material packages or contact the pharmacy 

12 for guidance. 

13 Preparation of radioactive materials for return as an excepted package of limited quantity 

14  Ensure that the activities of material being returned are limited quantities as defined by 

15 DOT in Table 4 of 49 CFR 173.425. Special attention will be given for the return of 

16 unused doses that may still contain significant activities of radionuclides. The amount of 

17 radioactivity in unused doses may necessitate that a syringe or vial be held for decay to 

18 reduce the activity to that permitted for shipment of limited quantities. 

19  Place the syringe or vial in the original, labeled shield in which it was delivered. 

20  Place shielded waste into the shipping package in which it was delivered. Note: 

21 Packages used to ship radioactive material to customers meet the DOT package 

22 requirements for transport of limited quantities. 

23 Preparation of Limited Quantity package 

24  Using a calibrated radiation survey meter, measure the radiation levels at all points 

25 on the surface of the package to ensure that levels are less than or equal to 0.5 mrem/hr 

26 (5.0 μSv/hr). 

27  Use contamination wipes on the surface of the package to ensure that the removable 

28 contamination does not exceed the limit specified in 49 CFR 173.443(a). Label the 

29 package as an “Excepted Package-Limited Quantity of Material.” 

30  Seal the package so that it will be evident upon receipt if the package was opened 

31 during shipment. 

32 Procedure for Receipt and Opening of Packages from Customers Containing 

33 Radioactive Waste 

34  Place all returned packages in an identifiable location within the radiopharmacy. 

35  Put on disposable gloves. 
P–2 

1  Monitor the package for removable contamination. If wipe tests indicate contamination 

2 levels greater than the limits of 10 CFR 20.1906(d)(1), notify the customer and the 

3 U.S. Nuclear Regulatory Commission, survey the driver or courier who retrieved the 

4 waste and the vehicle used to transport the waste to the radiopharmacy, and 

5 decontaminate the package or remove it from service for decay. 

6  Open the package and identify each nuclide in the shielded containers. 

7  Dispose of radioactive waste into the appropriate container for the half-life of the nuclide 

8 being disposed of, in accordance with the radiopharmacy’s procedures for disposal of 

9 waste by decay-in-storage. 

10 Survey the transport radiation shields for contamination with a low-level radiation survey meter. 

11 Decontaminate or remove from service any transport radiation shield that indicates activity 

12 exceeding low-background readings.
1 APPENDIX Q 

2 NRC INCIDENT NOTIFICATIONS

Q–1 

1 NRC Incident Notifications 

2 Table of Required Incident Notifications and Reporting 

3 Note: The following list of notification and reporting requirements is provided to inform 

4 licensees about typical notification and reporting requirements that apply to their licensed 

5 activities. Licensees should note that the list is incomplete in that not all potentially applicable 

6 requirements have been included. Also, notification and reporting requirements change; 

7 therefore, licensees should consult the regulations for definitive information about 

8 current requirements.

Table Q–1. Typical Notifications Required for Radiopharmacy Licensees 

Event 

Telephone 

Notification 

Written 

Report 

Regulatory 

Requirement 

Package received with removable 

radioactive surface contamination 

exceeding the limits of Title 10 of the Code 

of Federal Regulations (10 CFR) 71.87(i) or 

external radiation levels exceeding the 

limits of 10 CFR 71.47 

Immediate 

[NRC and final 

delivery carrier 

must be 

notified] 

None 10 CFR 20.1906(d) 

Theft or loss of material Immediate 30 days 10 CFR 20.2201(a)(1)(i) 

& 20.2201(b), 

Whole body dose greater than 0.25 Sv 

[25 rem] 

Immediate 30 days 10 CFR 20.2202(a)(1)(i) 

& 20.2203(a)(1) 

Extremity dose greater than 2.5 Gy 

[250 rads] 

Immediate 30 days 10 CFR 20.2202(a)(1)(iii) 

& 20.2203(a)(1) 

Whole body dose greater than 0.05 Sv 

[5 rem] in 24 hours 

24 hours 30 days 10 CFR 20.2202(b)(1)(i) 

& 20.2203(a)(1) 

Extremity dose greater than 0.5 Sv 

[50 rem] in 24 hours 

24 hours 30 days 10 CFR 20.2202(b)(1)(iii) 

& 20.2203(a)(1) 

Whole body dose greater than 0.05 Sv 

[5 rems] 

None 30 days 10 CFR 20.2203(a)(2)(i) 

Dose to individual member of public greater 

than 1 mSv [100 mrem] 

None 30 days 10 CFR 20.2203(a)(2)(iv) 

Defect in equipment that could create a 

substantial safety hazard 

2 days 30 days 10 CFR 21.21(d)(3)(i) & (ii)

Event that prevents immediate protective 

actions necessary to avoid exposures to 

radiation or radioactive materials that could 

exceed regulatory limits 

Immediate 30 days 10 CFR 30.50(a) & (c)(2); 

40.60(a) & (c)(2); and 

70.50(a) & (c)(2) 

 
Q–2 

Table Q–1. Typical Notifications Required for Radiopharmacy Licensees (Continued)

Event

Telephone 

Notification

Written 

Report

Regulatory 

Requirement

Unplanned contamination event that 

requires restricted access for more than 

24 hours and involves a quantity of material 

greater than 5 times the lowest annual 

limits on intake for the material as specified 

in Appendix B of 10 CFR Part 20 and 

requires the area to be restricted for a 

reason other than to allow radionuclides 

with half-lives less than 24 hours to decay 

24 hours 30 days 10 CFR 30.50(b)(1) & 

(c)(2); 40.60(b)(1) & (c)(2); 

and 70.50(b)(1) & (c)(2) 

Equipment is disabled or fails to function as 

designed when required to prevent 

radiation exposure in excess of regulatory 

limits 

24 hours 30 days 10 CFR 30.50(b)(2) & 

(c)(2); 40.60(b)(2) & (c)(2); 

and 70.50(b)(2) & (c)(2) 

Unplanned fire or explosion that affects the 

integrity of any licensed material or device, 

container, or equipment with licensed 

material 

24 hours 30 days 10 CFR 30.50(b)(4) & 

(c)(2); 40.60(b)(4) & (c)(2); 

and 70.50(b)(4) & (c)(2) 

Intake of 5 times the annual limit on intake 

(ALI) 

Immediate 30 days 10 CFR 20.2202(a)(2) & 

20.2203(a)(1) 

Intake of one ALI 24 hours 30 days 10 CFR 20.2202(b)(2) & 

20.2203(a)(1) 

Filing petition for bankruptcy under 

U.S. Code Title 11 

None Immediately 

after filing 

petition 

10 CFR 30.34(h) 

Expiration of license None 60 days 10 CFR 30.36(d)(1) 

Decision to permanently cease licensed 

activities at entire site

None 60 days 10 CFR 30.36(d)(2) 

Decision to permanently cease licensed 

activities in any separate building or 

outdoor area that is unsuitable for release 

for unrestricted use 

None 60 days 10 CFR 30.36(d)(2) 

No principal activities conducted for 24 

months at the entire site

None 60 days 10 CFR 30.36(d)(3) 

No principal activities conducted for 24 

months in any separate building or outdoor 

area that is unsuitable for release for 

unrestricted use 

None 60 days 10 CFR 30.36(d)(4) 
Q–3 

Table Q–1. Typical Notifications Required for Radiopharmacy Licensees (Continued)

Event

Telephone 

Notification

Written 

Report

Regulatory 

Requirement

Determination that any licensee that has 

not previously implemented the Security 

Orders (i.e., orders issued by the NRC to 

require licensees to implement interim 

security measures) or been subject to the 

provisions of 10 CFR Part 37, Subpart C 

will aggregate radioactive material to a 

quantity that equals or exceeds the 

Category 2 threshold 

None 90 days 

before 

aggregating 

radioactive 

material to a 

quantity that 

equals or 

exceeds the 

Category 2 

threshold 

10 CFR 37.41(a)(3) 

Coordination with local law enforcement 

agency (LLEA) has failed, either because 

the LLEA has not responded or because 

the LLEA does not plan to participate 

3 business 

days 

Submittal of a 

written report 

concerning 

failures of 

coordination 

with LLEA as 

described in 

10 CFR 

37.45(b) is not 

required; 

however, 

licensees 

must 

document 

their efforts to 

coordinate 

with the LLEA 

and keep this 

documentation 

for 3 years 

10 CFR 37.45(b) 

Determination that an unauthorized entry 

resulted in an actual or attempted theft, 

sabotage, or diversion of Category 1 or 

Category 2 quantity of radioactive material 

As soon as 

possible (but 

not at the 

expense of 

causing delay 

or interfering 

with the LLEA 

response), but 

no later than 4 

hours after 

discovery 

30 days 10 CFR 37.57(a)&(c) 

Assessment of any suspicious activity 

related to possible theft, sabotage, or 

diversion of Category 1 or Category 2 

quantities of radioactive material 

As soon as 

possible, but 

no later than 4 

hours after 

notifying the 

LLEA 

None 10 CFR 37.57(b) 
Q–4 

Table Q–1. Typical Notifications Required for Radiopharmacy Licensees (Continued)

Event

Telephone 

Notification

Written 

Report

Regulatory 

Requirement

Determination that a shipment containing a 

Category 1 quantity of material is lost or 

missing in transport 

Within 1 hour 

of the 

determination. 

Also notify 

LLEA within 

1 hour of 

determination 

30 days and 

periodic 

updates 

10 CFR 37.81(a)&(g) 

Determination that a shipment containing a 

Category 2 quantity of material is lost or 

missing in transport 

Within 4 hours 

of the 

determination 

and again 

within 24 hours 

if the material 

has not yet 

been located 

and secured 

30 days 10 CFR 37.81(b)&(g) 

Discovery along the route of any actual or 

attempted theft or diversion, or suspicious 

activity, related to a Category 1 quantity of 

material in transport 

Upon 

discovery, as 

soon as 

possible. Also 

notify LLEA as 

soon as 

possible upon 

discovery 

30 days 

(except no 

report for 

suspicious 

activity) 

10 CFR 37.81(c)&(g) 

Discovery of any actual or attempted theft 

or diversion, or suspicious activity, related 

to a Category 2 quantity of material in 

transport 

As soon as 

possible 

30 days 

(except no 

report for 

suspicious 

activity) 

10 CFR 37.81(d)&(g) 

Upon recovery of any lost or missing 

Category 1 quantity of material 

As soon as 

possible. Also 

notify the LLEA 

as soon as 

possible 

To be included 

in the 30-day 

report of an 

event 

described in 

10 CFR 

37.81(g), if 

recovered 

during that 

time 

10 CFR 37.81(e)&(h) 
Q–5 

Table Q–1. Typical Notifications Required for Radiopharmacy Licensees (Continued)

Event

Telephone 

Notification

Written 

Report

Regulatory 

Requirement

Upon recovery of any lost or missing 

Category 2 quantity of material 

As soon as 

possible 

To be included 

in the 30-day 

report of an 

event 

described in 

10 CFR 

37.81(g), if 

recovered 

during that 

time 

10 CFR 37.81(f)&(h) 

Note: Telephone notifications must be made to the NRC Operations Center at 301-816-5100 or 

by facsimile to 301-951-0550, except as noted. The Center is staffed 24 hours a day and 

accepts collect calls. 
1 
1 APPENDIX R 

2 CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

3 INFORMATION FROM PUBLIC DISCLOSURE (UNDER 10 CFR 2.390) 

R–1 

1 Checklist for Requests to Withhold Proprietary Information from Public 

2 Disclosure (Under 10 CFR 2.390) 

In order to request that the U.S. Nuclear Regulatory Commission (NRC) withhold information 

from public disclosure, the applicant or licensee must submit the information, including an 

affidavit, in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 2.390, 

“Public inspections, exemptions, requests for withholding.” The applicant should submit all of 

the following: 

 A proprietary copy of the information. Brackets should be placed around the material 

considered to be proprietary. This copy should be marked as proprietary. 

 A nonproprietary copy of the information. Applicants should white out or black out the 

proprietary portions (i.e., those in the brackets), leaving the nonproprietary portions 

intact. This copy should not be marked as proprietary. 

 An affidavit that 

 Is signed under oath and affirmation (notarization may suffice). 

 Clearly identifies (such as by name or title and date) the document to be withheld. 

 Clearly identifies the position of the person executing the affidavit. This person 

must be an officer or upper-level management official who has been delegated the 

function of reviewing the information the organization is seeking to withhold and is 

authorized to apply for withholding on behalf of the organization. 

 States that the organization submitting the information is the owner of the 

information or is required, by agreement with the owner of the information, to treat 

the information as proprietary. 

 Provides a rational basis for holding the information in confidence. 

 Fully addresses the following issues: 

 Is the information submitted to, and received by, the NRC in confidence? 

Provide details. 

 To the best of the applicant’s knowledge, is the information currently available in 

public sources? 

 Does the applicant customarily treat this information, or this type of information, 

as confidential? Explain why. 

 Would public disclosure of the information be likely to cause substantial harm to 

the competitive position of the applicant? If so, explain why in detail. The 

explanation should include the value of the information to your organization, the 

amount of effort or money expended in developing the information, and the 

ease or difficulty for others to acquire the information. 

1 APPENDIX S 

2 SAFETY CULTURE POLICY STATEMENT 

S–1 

1 Safety Culture 

2 The Safety Culture Policy Statement was published in the Federal Register (76 FR 34773) on 

3 June 14, 2011, and can be found at: http://www.gpo.gov/fdsys/pkg/FR-2011-06-14/pdf/2011-

4 14656.pdf. It is also posted in the U.S. Nuclear Regulatory Commission (NRC) Agencywide 

5 Documents Access and Management System Accession Number ML11146A047. 

6 Safety Culture Policy Statement 

7 The purpose of this Statement of Policy is to set forth the Commission’s expectation that 

8 individuals and organizations establish and maintain a positive safety culture commensurate 

9 with the safety and security significance of their activities and the nature and complexity of their 

10 organizations and functions. This includes all licensees, certificate holders, permit holders, 

11 authorization holders, holders of quality assurance program approvals, vendors and suppliers of 

12 safety-related components, and applicants for a license, certificate, permit, authorization, or 

13 quality assurance program approval, subject to NRC authority. The Commission encourages 

14 the Agreement States, Agreement State licensees, and other organizations interested in nuclear 

15 safety to support the development and maintenance of a positive safety culture, as articulated in 

16 this Statement of Policy. 

17 Nuclear Safety Culture is defined as the core values and behaviors resulting from a collective 

18 commitment by leaders and individuals to emphasize safety over competing goals to ensure 

19 protection of people and the environment. Individuals and organizations performing regulated 

20 activities bear the primary responsibility for safety and security. The performance of individuals 

21 and organizations can be monitored and trended and, therefore, may be used to determine 

22 compliance with requirements and commitments and may serve as an indicator of possible 

23 problem areas in an organization’s safety culture. The NRC will not monitor or trend values. 

24 These will be the organization’s responsibility as part of its safety culture program. 

25 Organizations should ensure that personnel in the safety and security sectors have an 

26 appreciation for the importance of each, emphasizing the need for integration and balance to 

27 achieve both safety and security in their activities. Safety and security activities are closely 

28 intertwined. While many safety and security activities complement each other, there may be 

29 instances in which safety and security interests create competing goals. It is important that 

30 consideration of these activities be integrated so as not to diminish or adversely affect either; 

31 thus, mechanisms should be established to identify and resolve these differences. A safety 

32 culture that accomplishes this would include all nuclear safety and security issues associated 

33 with NRC-regulated activities. 

34 Experience has shown that certain personal and organizational traits are present in a positive 

35 safety culture. A trait, in this case, is a pattern of thinking, feeling, and behaving that 

36 emphasizes safety, particularly in goal conflict situations (e.g., production, schedule, and the 

37 cost of the effort versus safety). It should be noted that although the term ‘‘security’’ is not 

38 expressly included in the following traits, safety and security are the primary pillars of the NRC’s 

39 regulatory mission. Consequently, consideration of both safety and security issues, 

40 commensurate with their significance, is an underlying principle of this Statement of Policy.
S–2 

1 The following are traits of a positive safety culture: 

2 (1) Leadership Safety Values and Actions—Leaders demonstrate a commitment to safety in 

3 their decisions and behaviors, 

4 (2) Problem Identification and Resolution—Issues potentially impacting safety are promptly 

5 identified, fully evaluated, and promptly addressed and corrected commensurate with 

6 their significance, 

7 (3) Personal Accountability—All individuals take personal responsibility for safety, 

8 (4) Work Processes—The process of planning and controlling work activities is implemented 

9 so that safety is maintained, 

10 (5) Continuous Learning—Opportunities to learn about ways to ensure safety are sought out 

11 and implemented, 

12 (6) Environment for Raising Concerns—A safety conscious work environment is maintained 

13 where personnel feel free to raise safety concerns without fear of retaliation, intimidation, 

14 harassment, or discrimination, 

15 (7) Effective Safety Communication—Communications maintain a focus on safety, 

16 (8) Respectful Work Environment—Trust and respect permeate the organization, and 

17 (9) Questioning Attitude—Individuals avoid complacency and continuously challenge 

18 existing conditions and activities in order to identify discrepancies that might result in 

19 error or inappropriate action. 

20 There may be traits not included in this Statement of Policy that are also important in a positive 

21 safety culture. It should be noted that these traits were not developed to be used for 

22 inspection purposes. 

23 It is the Commission’s expectation that all individuals and organizations, performing or 

24 overseeing regulated activities involving nuclear materials, should take the necessary steps to 

25 promote a positive safety culture by fostering these traits as they apply to their organizational 

26 environments. The Commission recognizes the diversity of these organizations and 

27 acknowledges that some organizations have already spent significant time and resources in the 

28 development of a positive safety culture. The Commission will take this into consideration as 

29 the regulated community addresses the Statement of Policy. 



NUREG-1556, Vol. 13

Revision 2, Draft

Consolidated Guidance About Materials Licenses: Program-Specific 

Guidance About Commercial Radiopharmacy Licenses