NRC / Agreement State Licensing

Operational guide to obtaining and maintaining a byproduct-material license under the Nuclear Regulatory Commission or the equivalent program of an Agreement State. Required to receive, possess, use, and dispose of radioactive material in medical practice. The license is the gating regulatory document — without it, a PET / CT, SPECT, brachytherapy, Gamma Knife, or theranostic program cannot operate.

When a license is required

• PET / CT, PET / MR — F-18, Rb-82, Ga-68, C-11, Cu-64, Zr-89, calibration sources (Ge-68).
• SPECT / nuclear medicine — Tc-99m generator, Tl-201, I-131, In-111, Ga-67, Ra-223, Lu-177, Ac-225 (theranostics).
• Brachytherapy — Ir-192 HDR, I-125 / Pd-103 seeds, Cs-137 sources (legacy), Y-90 microspheres.
• Gamma Knife — Co-60 sealed sources (Part 35.600).
• Calibration / well-counter / survey-instrument sources — even imaging-only programs need licensed sealed sources for daily QC.

Requirements at a glance

• Licensed facility with named Authorized Users (AUs) per pathway.
• Radiation Safety Officer — qualified individual, named on the license, with documented authority.
• Documented radiation-safety program — written procedures, ALARA program, training records, dose records, surveys, written directives for therapy.
• Calibrated equipment — dose calibrator, survey meter, area monitors, contamination meters, with documented daily / weekly / annual QC.
• Waste management — decay-in-storage, licensed-broker disposal pathway, manifests, source-return chain of custody.
• Possession limits — licensed by isotope and activity; exceeding limits is a violation.
• Reporting — misadministration, contamination events above thresholds, lost / stolen sources.

License lifecycle

• New license — multi-month application; site visit / inspection before approval in many jurisdictions.
• License amendment — required for new isotopes, new AU additions, new modalities, decommissioning. Typically 30–120 days.
• License renewal — periodic (~5–10 years depending on type).
• Inspection cycle — every 1–5 years depending on license type and inspection history.
• Decommissioning amendment — final survey, inventory reconciliation, RSO sign-off; closeout inspection in some jurisdictions.

Authorized User pathways (10 CFR Part 35)

• 35.290 — diagnostic / imaging.
• 35.300 — unsealed-source therapy.
• 35.400 — manual brachytherapy.
• 35.500 — sealed-source diagnostics.
• 35.600 — sealed-source teletherapy / Gamma Knife.

Each has training, mentorship, and case-volume credentialing requirements.

Why it matters to buyers

• License transferability is NOT automatic on used-equipment purchases. The buying institution must hold a compatible license or amend its existing one before the equipment can receive isotopes.
• Amendment timelines drive install scheduling. A scanner can be physically installed and tuned weeks before the license amendment authorizes patient use.
• AU credentialing — physicians and physicists must be individually named on the license; staff changes are amendment events. Recruiting an AU is a license precondition for new programs.
• Decommissioning has its own license-amendment workload, often longer than the equipment removal itself.

Agreement States vs NRC

37 U.S. states are Agreement States with the NRC, regulating byproduct material under their own compatible programs. Federal facilities (VA, DoD, IHS) and non-Agreement States are licensed directly by the NRC. Agreement-state requirements sometimes go beyond NRC minimums.

Related

• Nuclear Regulatory Commission
• State Radiation Registration (X-ray equipment, separate framework)
• Radiation Safety Officer
• Nuclear Medicine Technologist
• Rad Onc Physicist
• Brachytherapy
• Cardiac Rubidium PET
• FDG PET Oncology