Medical radioactive materials licensing

Radioactive Materials License Amendment Preparation Guide

A practical way for radiology, oncology, urology, nuclear medicine, hospitals, and other medical facilities to organize a proposed change to an existing RAM or RML license.

Preparation checklist

Documents and decisions to organize

Do not send sensitive personnel records through the general website form. First describe the change and jurisdiction so a secure document process can be defined.

  • Current license: complete license and amendments, license number, expiration, regulator, authorized locations, materials, uses, quantities, personnel, and conditions.
  • Plain-language change: describe exactly what the facility wants to add, remove, relocate, replace, or revise and why the change is needed.
  • Target date: identify the desired implementation date, external dependencies, therapy launch, construction, staffing, inspection, or vendor commitments.
  • Regulatory jurisdiction: confirm NRC or Agreement State authority and the agency's current application, amendment, fee, submission, and signature process.
  • Materials and uses: identify the radionuclide, chemical or physical form, maximum possession, clinical use, and applicable medical-use category or license condition.
  • Personnel: identify the Authorized User, Authorized Medical Physicist, Radiation Safety Officer, physician, or other individual being added, removed, or changed, with the appropriate qualification pathway and records.
  • Rooms and locations: map receipt, storage, preparation, administration, imaging or treatment, surveys, waste, and other licensed activity locations affected by the change.
  • Facilities and equipment: identify shielding or occupancy review, survey instruments, dose measurement, security, contamination controls, storage, ventilation if relevant, and calibration needs.
  • Procedures: compare current radiation-safety and operating procedures to the proposed change, including written directives, surveys, spills, emergencies, medical events, patient release, records, and waste where applicable.
  • Training and implementation: identify affected staff, training, revised responsibilities, readiness checks, and the conditions that must be met before use begins.
  • Submission responsibility: designate the licensee representative who will review, approve, sign, pay any fee, submit to the regulator, answer questions, and retain the approval.
Common medical changes

Examples that need a jurisdiction-specific review

Start theranostics or another therapy

Review the isotope, medical use, Authorized User, rooms, equipment, procedures, training, patient release, waste, and whether the current license already covers the proposed program.

Add or remove personnel

Authorized User, Authorized Medical Physicist, RSO, physician, and other personnel changes can have different documentation and approval paths.

Add material, use, room, or location

The licensing impact depends on what is already authorized, how the new activity will be performed, and which facilities and procedures change.

Change operations or equipment

Equipment, workflow, possession, storage, waste, security, or procedure changes may need prior approval, notification, or internal documentation based on the license and regulator.

Official references

Current agency instructions control.

NUREG-1556, Volume 9

Review the NRC's current medical-use license guidance.

NRC Part 35 FAQs

Consult the NRC Part 35 frequently asked questions and the applicable Agreement State agency.

Materials licensing FAQs

The NRC's materials licensing FAQs provide general process information. State processes may differ.

Technical review: reviewed by an ABR-certified diagnostic medical physicist. Last reviewed September 2026. This guide is educational, not legal advice. The licensee remains responsible for regulatory decisions, approvals, signatures, submissions, fees, and compliance.

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