United States Nuclear Regulatory Commission - Protecting People and the Environment

Medical Uses Licensee Toolkit

This toolkit is designed to help licensees find key information easily. Contact Us to submit medical-related inquiries.

ANNOUNCEMENT:
The proposed rule to revise certain sections in 10 CFR Parts 30, 32, and 35, as well as the draft guidance to go with these proposed changes is now available for comment.  See Docket ID NRC–2008–0175 [the proposed rule] or Docket ID NRC–2014–0030 [the draft guidance] at regulations.gov.  Comments must be submitted by November 18, 2014.  For questions on the proposed rule, contact Neelam.Bhalla@nrc.gov.  For questions on the draft guidance, contact Donna-Beth.Howe@nrc.gov.

On this page:

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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:

Regulations and Medical Policy Statement

2014 Proposed Rule:

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
  • 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

See also:

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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.

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Emerging Technologies and 10 CFR 35.1000

On April 24, 2002, the United States Nuclear Regulatory Commission (NRC) published a final rule (67 FR 20250) which included a new section, "Subpart K – Other Medical Uses of Byproduct Material or Radiation From Byproduct Material."  10 CFR 35.1000 in Subpart K describes the process to obtain a license, or an amendment to a license, for a new medical use of byproduct material or radiation from byproduct material, which is not addressed in other parts of 10 CFR Part 35 (i.e., an emerging medical technology). The information in this section applies to NRC licensees.  Agreement States have the option to follow the same approach used by NRC or to adopt alternative approaches.

Below is an Emerging Technologies and 10 CFR 35.1000 Table: a current list of emerging technologies, status, and links to corresponding documents, if applicable.

If you have questions on any of the guidance listed below, please contact either the appropriate NRC Regional Office or Agreement State for assistance. General questions for a given Emerging Technology can be directed to the Medical Radiation Safety Team Leader, Michael Fuller.

Note: New entries will be added as additional emerging technologies 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.

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Emerging Technologies and 10 CFR 35.1000 Table
Emerging Technology Name Status Document(s)
Best Vascular, Inc. Beta-Cath Intravascular Brachytherapy (IVB) System Licensed under 35.1000 Licensing Guidance
I-125 Iotrex Liquid Brachytherapy Source in Cytyc GliaSite Radiation Therapy Systemm Licensed under 35.1000 Licensing Guidance
Iodine-125 and Palladium-103 Low Dose Rate Brachytherapy Seeds Used for Localization of Non-Palpable Lesions Licensed under 35.1000 Licensing Guidance
Leksell Gamma Knife Perfexion™ Licensed under 35.1000 Licensing Guidance
NeoVista, Inc's Epi-Rad90 (Sr-90) Ophthalmic System Licensed under 35.1000 Licensing Guidance
Nucletron seedSelectron® System, Isotron Brachytherapy Sources and Nucletron FIRST™ System Retracted Licensing Guidance Revision Notice
Radium-223 Dichloride Licensed under 35.300 MEMO: Licensing for Ra-223 Dichloride
TheraSphere and SIRSpheres Yttrium-90 Microspheres Licensed under 35.1000 Licensing Guidance (June 2012)
Supersedes:
Oct 2011
Jan 2011
Sept 2008
Aug 2008
Dec 2007
Sept 2007
Jan 2004
Oct 2002
ViewRay System for Radiation Therapy Licensed under 35.1000 Licensing Guidance

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Guidance

Draft Guidance for the Proposed Rule 'Medical Use of Byproduct Material—Medical Events Definitions, Training and Experience, and Clarifying Amendments.

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

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Other Guidance

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).

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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

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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
7
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

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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.

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Forms

The following forms are to be used by medical use licensees.

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Page Last Reviewed/Updated Friday, November 28, 2014