Medical Uses Licensee Toolkit
This toolkit is designed to help licensees find key information easily. Contact Us to submit medical-related inquiries.
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NRC - FDA Will Host a Workshop on Targeted Alpha Emitting Radiopharmaceuticals
On Wednesday, September 22, 2021, from 9:00 a.m. – 4:30 p.m. ET, the NRC and the U.S. Food and Drug Administration (FDA) will host a virtual workshop on targeted alpha emitting radiopharmaceuticals, with a focus on Actinium-225. For the agenda and information on how to participate, see the FDA’s workshop website.
NRC Information Notice Issued
On August 4, 2021, the NRC issued Information Notice 2021-02, “Recent Issues Associated with Monitoring Occupational Exposure to Radiation from Licensed and Unlicensed Radiation Sources.”
From August 2018 to October 2020, the NRC identified issues at seven NRC medical-use licensees involving compliance issues associated with monitoring individuals’ occupational exposure to radiation from licensed and unlicensed radiation sources that were under the control of the licensees. The NRC expects that recipients will review the information for applicability to their facilities and consider actions, as appropriate, to avoid similar problems.
NRC Grants Extension on Temporary Addendum
NorthStar requested an extension on their Temporary Addendum, due to continued COVID-19 related disruptions to businesses in the U.S. The NRC issued an extension until December 31, 2021 to the Temporary Addendum to Revision 1 of the NorthStar Medical Radioisotopes, LLC, "RadioGenix® Molybdenum-99/Technetium-99m Generator System Licensing Guidance for Medical Use."
NorthStar found that providing the training at or near their customer’s sites, resulted in a more streamlined training process, found it to be equally or more effective for the customer, and provided a safe and effective way to allow continued licensing of domestic Mo-99 in spite of the COVID-19 situation in the U.S. See Emerging Medical Technologies for more information.
NRC Video for Medical Patients and Families
This video, "Staying Safe While Getting Better, Protecting Yourself and Your Loved Ones While Taking Radioactive Drugs," may serve as an educational tool providing radiation safety guidance and precautions patients can follow before, during and after treatment with radiopharmaceuticals. This video was created by the NRC since patients may seek social media for information about their treatments with radiopharmaceuticals. Licensees and professional societies are welcome to distribute the video as they see fit.
Medical List Server
NRC maintains a medical list server for automatic e-mail notifications of medical-related information, and Federal Register Notices. All interested stakeholders are welcome to subscribe.
Evaluation of Training and Experience
The NRC is evaluating the training and experience requirements for administering different categories of radiopharmaceuticals for which a written directive is required in accordance with 10 CFR Part 35, "Medical Use of Byproduct Material," Subpart E, "Unsealed Byproduct Material – Written Directive Required." For additional information on this evaluation, including activities, public involvement, and schedule, please see Training and Experience Evaluation.
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 19 – Notices, Instructions and Reports to Workers: Inspection and Investigations
- Part 20 – Standards for Protection Against Radiation
- Part 21 – Reporting of Defects and Noncompliance
- Part 30 – Rules of General Applicability to Domestic Licensing of Byproduct Material
- Part 32 – Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material
- Part 33 – Specific Domestic Licenses of Broad Scope for Byproduct Material
- Part 35 – Medical Use of Byproduct Material
- Part 37 – Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material
- Part 40 – Domestic Licensing of Source Material
- Part 70 – Domestic Licensing of Special Nuclear Material
Supporting information for the regulations and rulemaking activities are found in Background Information for Medical Licensees.
NUREG-1556; "Consolidated Guidance About Materials Licenses"
- Volume 5, Rev. 1, Program-Specific Guidance About Self-Shielded Irradiator Licenses
- Volume 6, Rev. 1, Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses
- Volume 7, Rev. 1, Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope, Including Electron Capture Devices and X-Ray Fluorescence Analyzers
- Volume 9, Rev. 3, Program-Specific Guidance About Medical Use Licenses
- Volume 10, Rev. 1, Program-Specific Guidance About Master Materials Licenses
- Volume 11, Program-Specific Guidance About Licenses of Broad Scope
- Volume 13, Revision 2, Program-Specific Guidance About Commercial Radiopharmacy Licenses
- Volume 17, Rev. 1, Program-Specific Guidance About Licenses for Special Nuclear Material of Less than Critical Mass
- Volume 21, Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator
NUREG-2155, "Implementation Guidance for 10 CFR Part 37, "Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material"
NUREG-2166, "Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material"
NUREG/CR-6345; Radiation Dose Estimates for Radiopharmaceuticals
To understand the basis for the NRC's medical-use regulations, background information can be found in the Federal Register Notices Related to Medical Licensees.
Regulatory Guides (RGs) are issued in 10 divisions and are intended to aid licensees in implementing regulations. The RGs most applicable to medical use can be found in Medical, Industrial, Academic Uses of Nuclear Materials Regulations, Guidance, and Communications.
NRC’s regional offices (Region I – East, Region III – Midwest, and Region IV – West/Southwest) typically conduct 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. More information can be found on Inspection of Medical, Industrial, and Academic Uses of Nuclear Material. The following Inspection Procedures are 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 Stereotactic Radiosurgery and Teletherapy Programs
- IP 87134 – Medical Broad-Scope Programs
Records of NRC inspection, including a description of applicable enforcement, are available in NRC's Agencywide Documents Access and Management System (ADAMS). In order to obtain electronic copies of publicly-available inspection reports by using the Sample Search Template, the license number is required. Publicly-available inspection reports can also be obtained from the NRC Public Document Room. Agreement state inspection reports will not be found in ADAMS or the NRC Public Document Room.
To ensure transparency with our stakeholders, the NRC also maintains descriptions of Significant Enforcement Actions for Material Licensees, sorted by date and a database of Significant Enforcement Actions for Material Licensees, sorted alphabetically. For additional information on how the NRC enforces applicable regulations, see Enforcement.
Operating experience is an essential element in the regulatory process for ensuring that licensed activities are conducted safely. The reporting and analysis of medical events helps to identify deficiencies in the safe use of radioactive material and to help ensure that corrective actions are taken to prevent recurrence. A medical event may indicate a potential problem in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. Medical event reporting also allows the NRC to follow up on events and determine if other licensees might be experiencing the same or similar challenges. The NRC assesses trends or patterns, identifies generic issues or concerns, and recognizes any inadequacy or unreliability of specific equipment or procedures. When the NRC identifies similarities in the problems reported from multiple facilities, the NRC issues generic communications that may help prevent additional incidents.
Medical licensees are required to report medical events in accordance with:
||Report and notification of a medical event.
||Report and notification of a dose to an embryo/fetus or a nursing child.
||Report of a leaking source.
In addition to medical events, licensees are required to report events in accordance with 10 CFR Part 20, Subpart M, "Reports," 10 CFR Part 21, "Reporting of Defects and Noncompliance," and 10 CFR 30.50, "Reporting requirements."
The secure database which contains the reported events is not accessible by the public. However, the NRC's Advisory Committee on the Medical Uses of Isotopes conducts semiannual meetings in which the NRC staff and ACMUI give presentations on the medical events from the past fiscal year. Included in the presentation are the causes of those events if known. Below are the presentation slides:
High Dose-Rate Remote Afterloader Brachytherapy Devices
The NRC and the Food and Drug Association (FDA) co-regulate high dose-rate remote afterloader brachytherapy devices. A list of high dose-rate remote afterloader brachytherapy devices that are FDA-cleared for patient treatment using sources exceeding 10 Curies is provided for your convenience. The NRC will not authorize the use of sources exceeding 10 Curies in afterloaders unless the FDA has cleared them.
Licensees and applicants should consult NUREG 1556 Volume 9, Rev. 2, "Program-Specific Guidance About Medical Use Licenses," for the information that should be submitted to support a new license, amendment, or renewal of a medical use.
When completing a U.S. NRC medical use license, the author must complete the "Authorized Use" (item 9) and "User Authorization sections of the license. The Table of 35.300 Authorizations has provided sample language for common licensing actions.
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.
Licenses with multiple activities may be assigned multiple program codes. When a licensee has more than one program code, the code with the shortest inspection cycle is designated as the highest priority. This code is designated as the primary code.
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 the licensee is a medical facility, private practice, mobile service, or laboratory.
||License Type (Program Code)
|Medical Institution Broad
||9 & 11
|Medical Institution – Written Directive Required
|Medical Institution – Written Directive Not Required
|Medical Private Practice – Written Directive Required
|Medical Private Practice – Written Directive Not Required
|Mobile Medicine Service – Written Directive Not Required
|Mobile Medical Service – Written Directive Required
|Medical Therapy – Other Emerging Technology
|In Vitro Testing Laboratories*
* 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 Type (Program Code)
|Eye Applicators Strontium-90
|High Dose Rate Remote Afterloader
|Gamma Stereotactic Radiosurgery
|Pacemaker Byproduct and/or SNM – Medical Institution
|Pacemaker Byproduct and/or SNM – Individual
|Source Material Shielding
Additional License Types (Program Codes) Associated with Medical Use
The code used depends upon radiation program authorizations.
||License Type (Program Code)
|Research and Development Type A Broad*
|Research and Development Type B Broad*
|Research and Development Type C Broad*
|Research and Development Other*
|Measuring Systems Analytic Gauges
|Measuring Systems Gas Chromatographs
|Measuring Systems Other
|Irradiators Self-Shielded Less than or Equal to 10,000 Curies
|Irradiators Other Less than or Equal to 10,000 Curies
|Irradiators Self Shielded Greater than 10,000 Curies
|Waste Disposal (Burial)
|Incineration - Noncommercial (Secondary Code)
|Byproduct Material Possession Only - Permanent Shutdown
|Byproduct Material Standby - No Operations
|Decommissioning of Byproduct Material Facilities
|Low Level Waste Storage - Other (Secondary Code)
* does not include research on human subjects
Medical use licensees are required to pay an annual license fee to the NRC. Refer to the schedule of materials fees for the fees required for each category of license and each type of fee. Program Codes are provided in the section above.
The following Forms and Instructions are to be used by medical use licensees.
- Reciprocity Form 214
- Training and Experience NRC Form 313A Series of Forms and Guidance
- License Application Form 313
- Disposition of Materials Form 314
- NRC Form 3, Notice to Employees
- NRC Form 4, Cumulative Occupational Dose History
- NRC Form 5, Occupational Dose Record for a Monitoring Period
Page Last Reviewed/Updated Friday, August 27, 2021