Medical Uses Licensee Toolkit
This toolkit is designed to help licensees find key information easily. Contact Us to submit medical-related inquiries.
On this page:
- Shortages of Molybdenum-99/Technetium-99m
- Regulations and Medical Policy Statement
- Medical List Server
- Guidance
- Other Guidance
- Inspection Procedures
- License Types
- Fees
- Forms
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Some of the links on this page are to non-NRC servers and websites and are provided solely as a reference for the convenience of users. NRC cannot guarantee the authenticity of documents or the validity of information obtained at these non-NRC websites. See our Site Disclaimer for more information.
Shortages of Molybdenum-99/Technetium-99m
Since December 2007, the industry has experienced intermittent shortages of molybdenum-99 (Mo-99) as a result of unplanned reactor outages. These outages are significant because the world's supply of medical Mo-99 is primarily produced by five aging reactors in Canada, Europe, and South Africa, and Mo-99 is required to produce Mo-99/technetium-99m (Tc-99m) generators for medical uses. For additional information regarding these shortages, see the following Government and industry Web resources of interest to medical use licensees:
- NRC exemption to certain provisions of 10 CFR Parts 32 and 35 for medical use licensees during Mo-99 shortages in the United States (July 16, 2009)
- Status update from Atomic Energy of Canada Limited (AECL) regarding its National Research Universal (NRU) reactor (the Canadian reactor responsible for production of medical Mo-99)
- Shortage updates from Tc-99m generator manufacturers
- Drug shortage information from the U.S. Food and Drug Administration (FDA)
- Medical information and strategies from the Society of Nuclear Medicine
Regulations and Medical Policy Statement
The NRC's regulations are found in Chapter I of Title 10, "Energy," of the Code of Federal Regulations (CFR). Chapter I is divided into Parts 1 through 199. The following parts contain the requirements most relevant to medical use of nuclear materials:
- Part 35 – "Medical Use of Byproduct Material"
- Final Rule, 10 CFR Parts 20, 32, and 35; Medical Use of Byproduct Material
- Part I, 67 FR 20249
- Part II, 67 FR 20299
- Part III, 67 FR 20349
- Direct Final Rule, Clarifying and Minor Amendments, 68 FR 19321
- Final Rule, Extending Expiration Date for 10 CFR Part 35 Subpart J, 69 FR 55736
- Final Rule, Medical Use or Byproduct Material – Recognition of Specialty Boards, 70 FR 16336
- Correcting Amendment, Medical Use of Byproduct Material—Recognition of Specialty Boards; Correction, 71 FR 1926
- Final Rule, 10 CFR Parts 1, 13, 20, 30, 32, 35, 40, 55, 70, 73, 110, and 140, 71 FR 15005
- Direct Final Rule, Medical Use of Byproduct Material - Minor Corrections and Clarifications, 72 FR 45147
- NARM Rule, "Requirements for Expanded Definition of byproduct Material (NARM)" - 72 FR 55864 - final rule
- NARM, "Notification of the Plan for the Transition of Regulatory Authority Resulting From the Expanded Definition of Byproduct Material" 72 FR 59157
- Direct final rule, Medical Use of Byproduct Material—Authorized User Clarification, 72 FR 33901
- Medical Policy Statement
- Part 40 – "Domestic Licensing of Source Material"
- Part 70 – "Domestic Licensing of Special Nuclear Material"
- Petitions for Rulemaking
- Peter G. Crane
Petition 70 FR 75752
Resolution 73 FR 29445 - William Stein, III, M.D.
Petition 71 FR 34285
Resolution 72 FR 60285 - E. Russell Rittenour, PhD
Petition 71 FR 64168
Resolution 73 FR 27773
See also:
- NARM Toolbox for information on the requirement for expanded definition of byproduct material (NARM)
- Medical, Industrial, Academic Uses of Nuclear Materials Regulations, Guidance, and Communications for other regulations, guidance documents, and generic communications that are applicable to all NRC licensees (including medical use licensees)
- Related resources of specific interest to medical use licensees:
Medical List Server
NRC has created a medical list server for automatic e-mail notifications of medical-related generic communications, NMSS/FSME Newsletters, and Federal Register Notices.
Guidance
Consolidated materials guidance is published in "Consolidated Guidance About Materials Licenses" (NUREG-1556).
- Volume 9, Rev. 2, Program-Specific Guidance About Medical Use Licenses
- Volume 11, Program-Specific Guidance About Licenses of Broad Scope
- Volume 13, Revision 1, Program-Specific Guidance About Commercial Radiopharmacy Licenses
- Volume 21, Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator
Other Guidance
- Guide for Diagnostic Nuclear Medicine - The American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM), in 2002, published a "Guide for Diagnostic Nuclear Medicine." This guide provides information that was current on October 24, 2002 and maybe useful to nuclear medicine professionals in understanding the applicability of NRC requirements at that time for the medical use of byproduct material in diagnostic settings and provides measures that practitioners may use to facilitate implementation of the October 2002 revised 10 CFR Part 35. Note: This document has not been updated to included changes to the training and experience requirements issued in March 30, 2005 in the "Final Rule, Medical Use of Byproduct Material - Recognition of Specialty Boards."
- Erratum for SNM "Guide for Diagnostic Nuclear Medicine" (December 20, 2002)
- Questions and Answers About Licensing Medical Uses of Byproduct Material Under Revised 10 CFR Part 35
- Radiation Dose Estimates for Radiopharmaceuticals (NUREG/CR-6345), April 1996
- Part 35 Stakeholder Workshop Slide Presentations
- Procedures for Recognizing Certification Process of Specialty Boards
- Specialty Boards Certification Recognized by NRC in accordance with 10 CFR Part 35 Subparts B, D, E, F, G, and H
- Complying with 10 CFR 35.400(a), 35.500(a), and 35.600(a) requirements for licensees to only use sources and devices "as approved in the Sealed Sources and Devices Registry" and "Sealed Source and Device Registry: Supplement for 10 CFR Part 35 Uses."
- Licensing Guidance for 10 CFR 35.1000 sealed sources and devices
Note: New entries will be added to the list as additional sealed sources and devices regulated under 10 CFR 35.1000 are identified. Licensing guidance will be updated when necessary to address comments from stakeholders. To submit comments on a specific licensing guidance document, contact the individual listed in that document or contact us using our electronic form. - Best Vascular, Inc. Beta-Cath Intravascular Brachytherapy (IVB) System
- I-125 Iotrex Liquid Brachytherapy Source in Cytyc GliaSite Radiation Therapy System
- Iodine-125 and Palladium-103 Low Dose Rate Brachytherapy Seeds Used for Localization of Non-Palpable Lesions
- Leksell Gamma Knife Perfexion TM
- NeoVista, Inc's Epi-Rad90 (Sr-90) Ophthalmic System
- Nucletron seedSelectron® System, Isotron Brachytherapy Sources and Nucletron FIRST™ System
- TheraSphere and SIRSpheres Yttrium-90 Microspheres June 2012 supersedes previous versions of licensing guidance dated October 2011, January 2011, September 2008, August 2008, December 2007, September 2007, January 2004, and October 2002.
- Standard license conditions for September 2008 yttrium-90 microsphere brachytherapy licensing guidance.
- Table of Authorizations - for unsealed byproduct material requiring a written directive. This table contains sample language for licensing actions completed after the revised 10 CFR 35 for the "authorized use" (item 9) and "user authorization" sections of a U.S. NRC medical use license.
- Procedures for Recognition of Foreign Trained Physicians and Physicists Applying for AU and AMP Status - provides guidance on making appropriate decisions regarding approval of foreign trained physicians and physicists applying for authorized user and authorized medical physicist status under the alternate pathway.
- High Dose-Rate Remote Afterloader Brachytherapy Devices Approved for Patient Treatment Using Sources Exceeding 10 Curies - provides a list of high dose-rate remote afterloader brachytherapy devices that are FDA-approved for patient treatment using sources exceeding 10 Curies.
Regulatory guides are issued in 10 divisions and are intended to aid licensees in implementing regulations. The guides most applicable to medical use are in Division 8, Occupational Health. (See the detailed list of Division 8 regulatory guides in Medical, Industrial, Academic Uses of Nuclear Materials Regulations, Guidance, and Communications for guides with general applicability to medical uses.)
Web (HTML) versions of some regulatory guides are available for viewing or downloading at this site. In the index for each division of guides, the number of each guide available at this site is underscored. All active final and draft guides are also available in NRC’s Agencywide Documents Access and Management System (ADAMS).
Inspection Procedures
NRC’s regional offices (Region I - East, Region III - Midwest, and Region IV - West/Southwest) conduct typically unannounced, periodic inspection of licensed activities using guidance from NRC's Inspection Manual, Chapter 2800. The frequency of inspection is based on the hazard of materials used. The following address inspections directly related to medical use.
- IP 87130 – Nuclear Medicine Programs, Written Directive Not Required
- IP 87131 – Nuclear Medicine Programs, Written Directive Required
- IP 87132 – Brachytherapy Programs
- IP 87133 – Medical Gamma Sterotactic Radiosurgery and Teletherapy Programs
- IP 87134 – Medical Broad-Scope Programs
License Types
NRC assigns a five-digit code to each license to designate the major activity or principal use authorized in the license. These codes may be used to identify the appropriate NUREG-1556 guidance documents and secondary activities or uses authorized in the license. NRC uses approximately 100 program codes to classify the primary and secondary activities of thousands of active licenses. Additional information provided in the description of each license type may be used to identify the fee categories information in the schedules in 10 CFR Part 170 and 10 CFR Part 171. To learn more about the license category and the associated fee and inspection categories, see "Consolidated Guidance About Materials Licenses: Guidance About Administrative Licensing Procedures" (NUREG-1556, Vol. 20, Appendix G: LTS Program Code Descriptions).
License Types (Program Codes) for Medical Facilities, Practices, Laboratories
The code used depends upon whether licensee is a medical facility, private practice, mobile service, or laboratory.
License Title | License Type (Program Code) | NUREG-1556 Vol. |
---|---|---|
Medical Institution Broad | 02110 | 9 & 11 |
Medical Institution Written Directive Required | 02120 | 9 |
Medical Institution Written Directive Not Required | 02121 | 9 |
Medical Private Practice Written Directive Required | 02200 | 9 |
Medical Private Practice Written Directive Not Required | 02201 | 9 |
Mobile Medicine Service Written Directive Not Required | 02220 | 9 |
Mobile Medical Service Written Directive Required | 02231 | 9 |
Medical Therapy Other Emerging Technology | 02240 | 9 |
In Vitro Testing Laboratories* | 02410 | 9 |
* not medical use but may be used for medical facilities and practices when it is the only byproduct material used
Additional License Types (Program Codes) Associated with Medical Use
The code used depends upon the medical device used.
License Title | License Type (Program Code) | NUREG-1556 Vol. |
---|---|---|
Eye Applicators Strontium-90 | 02210 | 9 |
High Dose Rate Remote Afterloader | 02230 | 9 |
Teletherapy | 02300 | 9 |
Gamma Stereotactic Radiosurgery | 02310 | 9 |
Pacemaker Byproduct and/or SNM Medical Institution | 22160 | 17 |
Pacemaker Byproduct and/or SNM Individual | 22161 | 17 |
Source Material Shielding | 11210 | 17 |
Additional License Types (Program Codes) Associated with Medical Use
The code used depends upon radiation program authorizations.
License Title | License Type (Program Code) | NUREG-1556 Vol. |
---|---|---|
Research and Development Type A Broad* | 03610 | 11 |
Research and Development Type B Broad* | 03611 | 11 |
Research and Development Type C Broad* | 03612 | 11 |
Research and Development Other* | 03620 |
|
Measuring Systems Analytic Gauges | 03122 | 7 |
Measuring Systems Gas Chromatographs | 03123 | 7 |
Measuring Systems Other | 03124 | 7 |
Irradiators Self-Shielded Less than or Equal to 10,000 Curies | 03510 | 5 |
Irradiators Other Less than or Equal to 10,000 Curies | 03511 | 6 |
Irradiators Self Shielded Greater than 10,000 Curies | 03520 | 5 |
Waste Disposal (Burial) | 03231 | |
Incineration - Noncommercial (Secondary Code) | 03235 | |
Byproduct Material Possession Only - Permanent Shutdown | 03800 | |
Byproduct Material Standby - No Operations | 03810 | |
Decommissioning of Byproduct Material Facilities | 03900 | |
Low Level Waste Storage - Other (Secondary Code) | 06101 |
* does not include research on human subjects
Fees
Medical use licensees are required to pay an annual license fee to the NRC. These fees are explained in our Materials Fee Billing Handbook. Refer to the schedule of materials fees for the fees required for each category of license and each type of fee.
Forms
The following forms are to be used by medical use licensees.
- Reciprocity Form 214
- Training and Experience NRC Form 313A Series of Forms and Guidance
- NRC Form 313A(RSO) - Radiation Safety Officer
- NRC Form 313A(AMP) - Authorized Medical Physicist
- NRC Form 313A(ANP) - Authorized Nuclear Pharmacist
- NRC Form 313A(AUD) - Authorized User 35.100, 35.200, 35.500 uses
- NRC Form 313A(AUT) - Authorized User 35.300 uses
- NRC Form 313A(AUS) - Authorized User 35.400, 35.600 uses
- Guidance for the NRC 313A Forms
- License Application Form 313
- Disposition of Materials Form 314
- NRC Form 3
- NRC Form 4
- NRC Form 5