NRC Radioactive Material License: Medical Use

Any facility that receives, possesses, or uses radioactive material for medical purposes must hold an appropriate license from either the Nuclear Regulatory Commission (NRC) or an Agreement State agency before use.¹² The license is the legal foundation of every nuclear medicine, PET/CT, and radiopharmaceutical therapy program, and it defines exactly which radionuclides, activities, and procedures a facility is authorized to perform.

Medical use is governed primarily by 10 CFR Part 35, layered on the general radiation protection standards of 10 CFR Part 20 and the general domestic licensing provisions of 10 CFR Part 30.¹²³ Applications to the NRC are filed on NRC Form 313 following the program-specific guidance in NUREG-1556, Volume 9, and the use categories you request on that application determine virtually every downstream requirement.⁴⁵ This guide walks through the licensing framework, the Part 35 use categories, what a complete application requires, how to designate an RSO and Authorized Users, the ALARA and source-security expectations, the NRC-versus-Agreement-State distinction, and how to keep a license in good standing. It is written for the technologists, physicists, Radiation Safety Officers, and administrators who build and maintain these programs in Florida, Maryland, Virginia, Washington DC, California, and Nevada.

Introduction

A radioactive material license is a legal authorization to handle "byproduct material" for a defined purpose. The license is not paperwork that sits in a drawer; it actively shapes the clinical formulary, who may direct each procedure, the activity a facility may hold, and the safety program that surrounds every administration. Understanding the structure of the regulations before you apply is what turns a months-long, deficiency-letter-plagued submission into a clean approval.

The federal framework is deliberately tiered. 10 CFR Part 30 establishes the general rules for who may possess byproduct material and the basic conditions of any materials license.³ 10 CFR Part 20 sets the radiation protection standards — occupational and public dose limits, ALARA, monitoring, posting, and waste — that apply to every licensee.¹ 10 CFR Part 35 then adds the medical-use-specific requirements: training and experience for Authorized Users, written directives, dosimetry of unsealed and sealed sources, and the procedure-based use categories that organize the whole rule.² A medical license is best understood as Part 35 sitting on top of Part 30 and Part 20.

Topic Explanation

A medical-use license authorizes specific procedures, not just possession of isotopes. Two regulatory pathways exist, and a facility applies to whichever authority has jurisdiction over its physical location.

• NRC direct regulation. The NRC issues and enforces licenses in non-Agreement States, Washington DC, and certain federal facilities. NRC applicants file NRC Form 313 and follow NUREG-1556, Volume 9, the consolidated program-specific guidance for medical-use licenses.⁴⁵
• Agreement State regulation. A state that has signed an agreement with the NRC regulates radioactive material within its borders through its own radiation control program. Agreement State rules must be compatible with, and at least as stringent as, the corresponding NRC requirements, so the technical content of a state application closely mirrors NUREG-1556.⁶

The application forms, fee schedules, and submission portals differ by regulator, but the underlying technical expectations are largely parallel.

Key Terms

• Byproduct material: Radioactive material subject to NRC or Agreement State licensing, including the Tc-99m, F-18, I-131, Lu-177, and similar radionuclides used in medical imaging and therapy.³
• Authorized User (AU): A physician named on the license who is approved to direct specific medical uses and who meets the training and experience criteria in the relevant 10 CFR Part 35 subpart.²
• Radiation Safety Officer (RSO): The individual named on the license who is responsible for implementing the radiation safety program and who meets the training and experience criteria of 10 CFR 35.50.²
• Possession limit: The maximum activity of each radionuclide a facility is authorized to hold at one time.
• Written directive: A signed, dated order by an Authorized User required before certain therapeutic and high-activity administrations under 10 CFR 35.40.²

Key Technical Principles

Medical-use licenses are structured around what a facility intends to do, not just what it owns. The scope of authorized use drives nearly every other requirement, and 10 CFR Part 35 organizes that scope into procedure-based use categories.

The 10 CFR Part 35 Medical-Use Categories

The single most important decision in a license application is which Part 35 use categories to request. Each category carries its own Authorized User training and experience criteria, its own survey, calibration, and instrumentation requirements, and — for the therapy and high-activity categories — written-directive and procedural obligations. The table below summarizes the categories and representative agents.

Note that several modern theranostic agents are licensed under §35.1000 because they postdate the fixed categories; the NRC issues product-specific guidance (training, instrumentation, release criteria) for each, and a license must reference the applicable guidance.⁵ For more on the radionuclides themselves, see our overview of common PET and radiopharmaceutical-therapy isotopes.

License Tiers in Practice

Although the NRC categorizes medical licenses by the 10 CFR 35 use categories above, facilities commonly fall into one of two practical tiers:

Clinic-Level License

Appropriate for facilities with a narrower scope of use, typically built around §35.100 and §35.200:

• Smaller facilities with limited radioactive material use
• Standalone imaging centers
• Basic diagnostic nuclear medicine programs
• Lower possession (activity) limits

Hospital-Level License

Required for facilities with a broader scope of use that often spans §35.300 through §35.600:

• Larger facilities with extensive radioactive material programs
• Facilities operating PET/CT systems
• Therapeutic applications such as radiopharmaceutical therapy and brachytherapy
• Higher possession (activity) limits
• More complex radiation safety programs

Authorized Uses Drive Requirements

The use categories determine which Authorized User training and experience criteria apply, what written directives and procedures are needed, and which survey, calibration, and instrumentation requirements attach to the license. A facility that requests §35.300 unsealed therapy or §35.600 remote-afterloader authority, for example, takes on substantially more rigorous AU qualification, dosimetry, and emergency-procedure obligations than one limited to §35.200 imaging.²

Clinical Impact

The license actively shapes clinical operations.

• It defines the formulary. A facility can only administer radionuclides and uses listed on its license. Adding a new agent, such as a Lu-177 therapy under §35.300 or §35.1000, requires the appropriate authorized use and a license amendment before the first patient is treated.
• It governs who can do what. Only physicians listed as Authorized Users may direct authorized medical uses, and the RSO named on the license carries program responsibility.
• It sets the safety baseline. Possession limits, survey requirements, and dose constraints flow from the license and the underlying 10 CFR Part 20 and 10 CFR Part 35 requirements, directly influencing patient release criteria, room shielding, and staff exposure.¹²

Operating outside license conditions, even briefly, is a regulatory violation that can trigger enforcement, fines, or suspension of authorized activities.

Application Requirements

A complete medical-use license application demonstrates that the facility, its people, and its program are ready to handle radioactive material safely. For NRC applicants, the package is built on NRC Form 313 with attachments organized around the items in NUREG-1556, Volume 9.⁴⁵ Applications generally must include the following.

Facility Information

• Facility name and address
• Contact information
• Facility type and size
• Number of authorized users

Equipment and Material Specifications

• Types of equipment using radioactive material
• Maximum activities (possession limits) to be possessed
• Radionuclides to be used and their intended medical uses (mapped to Part 35 categories)
• Equipment and use locations

Radiation Safety Program

A comprehensive radiation safety program, including:

• Written radiation safety procedures
• An ALARA program consistent with 10 CFR 20.1101, including a written commitment by management to keep exposures as low as reasonably achievable¹
• Training program documentation
• Dose monitoring protocols
• Emergency and spill response procedures
• Source security and control procedures consistent with 10 CFR 20.1801–20.1802 (securing or maintaining constant surveillance of licensed material)¹
• Quality assurance programs

Personnel Qualifications

Documentation of qualified personnel:

• Authorized User training and experience meeting the applicable 10 CFR Part 35 subpart criteria
• Radiation Safety Officer qualifications meeting 10 CFR 35.50
• Training records
• Relevant certifications and licenses

Facility Layout

• Floor plans showing equipment and use locations
• Shielding information
• Storage and waste-decay areas
• Workflow diagrams

A strong radiation safety program and supporting shielding design are usually the most scrutinized parts of an application; thin documentation here is the leading cause of deficiency letters.

Designating the RSO and Authorized Users

The Radiation Safety Officer is the linchpin of the application. Under 10 CFR 35.50, the named RSO must meet specific training and experience criteria — typically board certification by an NRC-recognized board, or the requisite documented training and experience attested to by a preceptor.² The RSO's duties (10 CFR 35.24) include establishing and overseeing the radiation safety program, ensuring compliance with the license and regulations, and stopping unsafe operations. Many smaller facilities engage a qualified medical physicist or health physicist as their RSO or as RSO support, and that arrangement should be documented in the application.

Each Authorized User must meet the training and experience criteria for the categories they will direct (for example, 10 CFR 35.290 for imaging or 10 CFR 35.390 for unsealed therapy). The most common application snag is naming an AU who does not yet have a completed preceptor attestation or board certification on file for the requested category.

The Application Process and Timeline

Applying for a new license is a multi-step process, and the dominant variable in the timeline is the completeness of the initial submission. The steps below describe the typical NRC flow; Agreement States follow an equivalent sequence with their own forms.

Because incomplete applications generate deficiency letters that add weeks or months each, the single most effective way to shorten the timeline is to submit a complete, well-organized package the first time. Build realistic lead time into clinical and capital planning, especially when a new therapy line depends on the license.

License Amendment Process

A license amendment is required before making any change that falls outside the current license conditions, including:

• Adding new equipment
• Adding, removing, or changing Authorized Users or the RSO
• Modifying authorized procedures
• Increasing possession (activity) limits
• Adding new radionuclides or medical uses (including a new Part 35 use category)
• Facility modifications affecting the radiation safety program

The amendment workflow typically follows four steps:

1. Preparation of the amendment request
2. Compilation of the required supporting documentation
3. Submission to the regulatory agency (NRC or Agreement State)
4. Agency review and approval

The change cannot be implemented until the amendment is approved. Building amendment lead time into clinical and capital planning prevents costly delays, especially when launching a new therapy line such as a §35.300 or §35.1000 radiopharmaceutical.

Ongoing Compliance

Holding a license is a continuing obligation. License holders maintain good standing through internal audits, source security, periodic reporting, and readiness for regulatory inspection.

ALARA and Occupational Dose

Every licensee operates under the dose limits of 10 CFR 20.1201 — an occupational total effective dose equivalent (TEDE) limit of 5 rem (0.05 Sv) per year, with a lens-of-eye limit of 15 rem (0.15 Sv) per year and a skin and extremity limit of 50 rem (0.5 Sv) per year.¹ The public dose limit under 10 CFR 20.1301 is 0.1 rem (1 mSv) per year.¹ A declared pregnant worker is limited to 0.5 rem (5 mSv) over the gestation period under 10 CFR 20.1208.¹ Monitoring is required when an individual is likely to receive more than 10% of the applicable limit (10 CFR 20.1502).¹ The ALARA program required at application is a living obligation: exposures must be reviewed against these limits and against the facility's own investigational levels. For the mechanics of building that program, see our guide to occupational exposure monitoring programs.

Security and Control of Sources

Licensed material must be secured against unauthorized removal or access, or kept under constant surveillance, per 10 CFR 20.1801–20.1802.¹ Sealed sources and high-activity therapy material carry additional accountability, inventory, and (for risk-significant quantities) increased-controls expectations. A documented source inventory and leak-test schedule for sealed sources is a routine inspection item.

Periodic Audits

Regular audits of radiation safety program implementation review:

• Procedure compliance
• Training verification
• Dose monitoring review
• Documentation completeness

The frequency and scope of required program reviews are set by 10 CFR Part 35 and the license conditions; many programs perform internal audits on a quarterly cadence in addition to the required annual program review.

Reporting

Reporting requirements include:

• Summaries of program activities
• Dose monitoring results
• Program effectiveness reviews
• Any incidents, events, or violations — including medical events under 10 CFR 35.3045 — reported within the timeframes required by 10 CFR Part 20 and 10 CFR Part 35²

Inspections

Facilities are subject to routine and, where warranted, unannounced inspections that evaluate:

• License compliance
• Radiation safety program implementation
• Personnel qualifications
• Documentation completeness
• Facility conditions

Avoiding repeat findings is far easier than remediating them; see our overview of common radiation safety violations and how to avoid them for the issues inspectors cite most often.

Common Licensing Issues

The most frequent reasons applications and renewals stall include:

• Incomplete applications and missing attachments
• Insufficient or generic radiation safety programs (especially a boilerplate ALARA section)
• Personnel who do not yet meet AU or RSO qualification criteria for the requested category
• Inadequate documentation of training, surveys, or calibrations
• Facility or shielding design issues

License Renewal

Medical-use licenses are issued for a fixed term and must be renewed periodically, typically every 5 to 10 years depending on the regulator. Renewal generally requires:

• Updated facility and personnel information
• Program updates reflecting current operations
• A review of compliance history
• A timely renewal application

Filing a complete renewal application before the expiration date is important: under timely-renewal provisions, an existing license generally remains in effect while the regulator processes a renewal filed on time.

Regulatory Considerations

Jurisdiction determines who issues and enforces a facility's license:

• Agreement States regulate radioactive material within their borders through their own radiation control programs. Florida, Maryland, Virginia, California, and Nevada are all Agreement States, so facilities there license through the state rather than the NRC.⁶ Florida's program, for example, operates under Florida Administrative Code 64E-5, the state's radiation protection rules.⁷
• NRC direct regulation applies in non-Agreement States and federal settings, using NRC Form 313 and NUREG-1556, Volume 9.⁴⁵
• Washington DC is regulated directly by the NRC, not by an Agreement State program.

Wherever a facility is located, it must apply to the regulator with jurisdiction over that site, and Agreement State requirements remain at least as stringent as the federal NRC rules. For a deeper dive into one state's framework, see our guide to Florida radiation safety requirements for imaging centers.

It is worth keeping the regulatory boundary straight: the NRC and Agreement States regulate byproduct (radioactive) material under 10 CFR Parts 20, 30, and 35. Diagnostic X-ray machines — CT, radiography/fluoroscopy, and mammography — are regulated by the FDA and the states rather than licensed under Part 35, although those states adopt the same 10 CFR Part 20 dose limits. A facility running both a nuclear medicine program and X-ray equipment will hold a materials license for the former and register the latter with the state.

Frequently Asked Questions (FAQs)

Who must have an NRC or Agreement State license?

Any facility that receives, possesses, or uses radioactive (byproduct) material for medical purposes must hold an appropriate license before use. This covers nuclear medicine clinics, PET/CT centers, and hospitals performing diagnostic or therapeutic procedures under 10 CFR Part 35.

What is the difference between an NRC license and an Agreement State license?

The NRC directly licenses facilities in non-Agreement States, Washington DC, and certain federal sites. In an Agreement State, the state's own program issues and enforces licenses under requirements at least as strict as the NRC's. Florida, Maryland, Virginia, California, and Nevada are all Agreement States.

What are the 10 CFR Part 35 medical-use categories?

Part 35 groups medical uses by procedure: §35.100 (uptake, dilution, excretion), §35.200 (imaging and localization, including generators and kits), §35.300 (unsealed therapy), §35.400 (manual brachytherapy), §35.500 (sealed sources for diagnosis), §35.600 (remote afterloaders, gamma stereotactic, and teletherapy), and §35.1000 (emerging uses such as Lu-177 DOTATATE/PSMA, Ra-223, and Y-90 microspheres). A license authorizes only the categories you request.

What form do I use to apply for a medical-use license?

NRC applicants file on NRC Form 313 with supporting documents, following NUREG-1556 Volume 9. Agreement States use their own equivalent forms, but the technical content mirrors NUREG-1556 because state programs must be compatible with the NRC's.

How long does an NRC or Agreement State license last?

Medical-use licenses are issued for a fixed term and renewed periodically, often every 5 to 10 years depending on the regulator. A renewal application filed on time keeps the existing license in effect under timely-renewal provisions while the regulator reviews it.

What is the difference between a Radiation Safety Officer and an Authorized User?

The RSO oversees the entire radiation safety program and is named on the license. An Authorized User is a physician approved on the license to direct specific medical uses, such as nuclear medicine imaging or radiopharmaceutical therapy, and must meet the training and experience criteria for that Part 35 category.

When is a license amendment required?

Before adding equipment, changing Authorized Users or the RSO, raising possession limits, adding radionuclides or use categories, or making facility changes that affect the radiation safety program. Operating outside license conditions is a violation.

Key Takeaways

• Every medical facility using radioactive material must hold an NRC or Agreement State license before use, with medical use governed by 10 CFR Part 35 on top of 10 CFR Part 20 and 10 CFR Part 30.
• The license is organized around 10 CFR Part 35 use categories (§35.100 through §35.1000); the categories you request drive AU training, written-directive, survey, and instrumentation requirements.
• NRC applicants file NRC Form 313 following NUREG-1556, Volume 9; Agreement States use compatible equivalents.
• The NRC directly regulates non-Agreement States and Washington DC; Florida, Maryland, Virginia, California, and Nevada are Agreement States that license through their own programs.
• A complete radiation safety program — including an ALARA commitment (10 CFR 20.1101) and source security (10 CFR 20.1801–20.1802) — plus a qualified RSO and AUs is the core of the application and the leading determinant of approval speed.
• A license amendment is required before adding equipment, users, radionuclides, use categories, or higher possession limits, and the change cannot occur until approved.
• Licenses are renewed periodically (commonly every 5 to 10 years), and a timely renewal application keeps an existing license in effect during review.

How DRPS Can Help

License applications, amendments, and ongoing compliance are detailed and time-consuming, and a single weak section can stall a program for months. Diagnostic Radiation Physics Services (DRPS) supports facilities across Florida, Maryland, Virginia, Washington DC, California, and Nevada with:

• License application preparation and review, including Part 35 use-category scoping and NRC Form 313 / NUREG-1556 documentation
• Radiation safety program development and documentation, including ALARA and source-security procedures
• RSO services and Authorized User qualification support
• License amendment assistance for new equipment, users, and radionuclides
• Ongoing compliance support and audit readiness
• Inspection preparation and corrective-action support

Contact DRPS to discuss your radioactive material licensing needs or learn more about our radioactive material license support services and Radiation Safety Officer services.

Conclusion

A radioactive material license is the legal and operational backbone of any medical program that handles byproduct material. Knowing whether the NRC or an Agreement State has jurisdiction, scoping the application around the right 10 CFR Part 35 use categories, naming a qualified RSO and Authorized Users, and maintaining the license through disciplined ALARA, source security, amendments, audits, and inspection readiness keeps a program both compliant and clinically agile. Facilities that treat licensing as an ongoing safety program, rather than a one-time hurdle, spend less time on enforcement and more time on patients.

Related Resources

• Common PET & RPT isotopes
• Occupational exposure monitoring
• Common radiation safety violations
• Florida radiation safety requirements
• Radioactive material license support
• Radiation Safety Officer consulting

References

1. U.S. Nuclear Regulatory Commission. 10 CFR Part 20: Standards for Protection Against Radiation. ecfr.gov
2. U.S. Nuclear Regulatory Commission. 10 CFR Part 35: Medical Use of Byproduct Material. ecfr.gov
3. U.S. Nuclear Regulatory Commission. 10 CFR Part 30: Rules of General Applicability to Domestic Licensing of Byproduct Material. ecfr.gov
4. U.S. Nuclear Regulatory Commission. NRC Form 313: Application for Materials License. nrc.gov
5. U.S. Nuclear Regulatory Commission. NUREG-1556, Volume 9, Revision 3: Consolidated Guidance About Materials Licenses — Program-Specific Guidance About Medical Use Licenses. nrc.gov
6. U.S. Nuclear Regulatory Commission. Agreement State Program. nrc.gov
7. Florida Department of Health. Florida Administrative Code Chapter 64E-5: Control of Radiation Hazard Regulations. flrules.org