NRCNuclear Regulatory Commission

NRC is an independent US federal agency with five Commissioners appointed by the President and confirmed by the Senate. It does not regulate the medical use of radiation per se — only the use of byproduct material (radioisotopes produced as a byproduct of nuclear-reactor operation, plus accelerator-produced and naturally occurring radioactive material since the 2005 Energy Policy Act). The FDA regulates the radiopharmaceutical as a drug; NRC regulates the radioactive material itself. Both regimes apply simultaneously to a radiopharmacy.

Under Section 274 of the Atomic Energy Act, NRC can transfer regulatory authority for byproduct material to a state that adopts a programme "compatible" with NRC's rules. As of 2025, 39 US states are Agreement States. In those states the state radiation-control programme — not NRC directly — issues materials licenses, conducts inspections and enforces 10 CFR 20-equivalent rules. The substantive controls are equivalent; the inspecting body differs.

• Occupational annual TEDE — 5 rem (50 mSv).
• Occupational organ dose (except eye lens) — 50 rem (500 mSv).
• Lens of the eye — 15 rem (150 mSv).
• Shallow-dose to skin or extremity — 50 rem (500 mSv).
• Declared-pregnant worker — 0.5 rem (5 mSv) gestation-period total to the embryo / fetus.
• Minor — 0.5 rem (5 mSv) annual.
• Public — 0.1 rem (1 mSv) annual TEDE (10 CFR 20.1301).
• Effluent limits — Appendix B air + water concentrations.

ALARA (10 CFR 20.1003) requires operating below these limits to the extent reasonably achievable — administrative investigation + action levels are typically set at 10 % / 30 % of the limit.

Part 35 is the rulebook for medical use of byproduct material — diagnostic imaging, unsealed therapy, sealed-source brachytherapy. Key requirements:

• Authorised User (AU) — physician with the specified training + experience for each use (35.290 imaging, 35.390 oral I-131 therapy, 35.490 brachytherapy, 35.590 manual brachy, 35.690 remote afterloader, 35.490 / 35.990 written-directive-required therapy).
• Authorised Nuclear Pharmacist (ANP) — for licensees with in-house compounding.
• Radiation Safety Officer (RSO) — single named individual responsible for the radiation-protection programme.
• Written directive — required for any administration of I-131 sodium iodide > 30 µCi, parenteral therapy, sealed-source therapy. Verified at the bedside against the patient identification before administration.
• Medical event reporting — administration outside the written directive (dose ≥ 20 % off plan, wrong patient, wrong radionuclide, leaking sealed source) reported to NRC within 24 hours by phone + 15 days in writing per 35.3045.

• Specific license — issued for a named licensee + named uses; default for medical and radiopharmacy operations.
• General license — granted by rule to broad categories (e.g. sealed sources in measuring instruments); does not require an individual application.
• Application via NRC Form 313 + supporting documentation: radiation-protection programme, RSO qualifications, facility diagrams, dose-calibration procedure, security plan for quantities of concern.
• Initial license duration typically 5–10 years; renewal application due ≥ 30 days before expiry.

Following 9/11, NRC issued increasing-controls orders, then codified them in 10 CFR Part 37 ("Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material"). Quantities of concern include Co-60, Cs-137, Ir-192, Sr-90, Am-241 above category thresholds; medical / industrial sealed-source users must implement access controls, monitoring, transport security and trustworthiness reviews of authorised individuals.

Routine NRC (or Agreement State) inspections occur on a frequency-by-priority basis — typically every 1–5 years depending on programme complexity. Enforcement actions are graded:

• Non-cited violation — minor, corrected; recorded but no formal Notice of Violation.
• Notice of Violation (NOV) — formal, requires written response with corrective action.
• Civil penalty — escalated fine for significant or wilful violations.
• Order — modify, suspend or revoke license; immediately effective in serious cases.

Trends are published in the Enforcement Action and Significant Enforcement Actions databases on nrc.gov.

Easy to confuse, but the boundary is clean:

• NRC — the radioactive material (its source, possession, use, transfer, disposal); the radiation-safety programme; occupational + public dose.
• FDA — the drug product (identity, strength, quality, purity, sterility, GMP). 21 CFR 212 (PET CGMP), 21 CFR 211 (compounded radiopharmaceuticals under the 503A/503B framework), 21 CFR 200 series for IND / NDA / ANDA submissions.
• DOT / IATA — packaging + transport of radioactive material (49 CFR Parts 171–180; IATA DGR).

• Treating NRC and FDA as alternatives — both apply simultaneously to a radiopharmacy.
• Operating in an Agreement State without registering with the state programme.
• Written directive missing for therapy administrations.
• Medical-event report missed for a > 20 % dose deviation.
• Quarterly RSO ALARA review absent or undocumented.
• Sealed-source leak test not performed at the prescribed frequency (typically 6 months).
• Decommissioning funding plan absent for facilities holding sources above threshold.
• DOT shipping papers not completed for radwaste transport.