RAM Licensing & Regulatory

Authorized User (AU)

AUs are the prescribing physicians approved to use RAM under the institution's RAM license — ensuring safe, compliant administration. For Ac-225-based RLT, the AU must be authorized specifically for parenteral (intravenous) administration of an alpha-emitting radiopharmaceutical.

Responsibilities

Safe handling and use

Ensuring RAM is handled and used in accordance with federal and state requirements and the facility's RAM license.

Training

Completing radiation safety training commensurate with authorizations for use, plus role-specific training in alpha radiobiology and Ac-225 administration.

Written directive & dosing

Prescribing the radiopharmaceutical and administered activity, signing the written directive, and ensuring administration matches the directive — per 10 CFR §35.40 / §35.41.

Staff supervision

Directing the individuals preparing and administering the dose, ensuring staff are adequately trained and follow approved procedures.

For an Ac-225 program, the AU is typically a nuclear medicine physician, radiation oncologist, or radiologist. AU training for parenteral administration of an alpha emitter follows §35.390 (or an alternate pathway documented in the license) — including didactic training and supervised work experience in the handling of radioactive materials.

Certification methods

Method 1 — Board certification

Board certification by an NRC- or Agreement State-recognized medical specialty board, plus documentation of classroom and laboratory training, supervised work experience, supervised clinical case experience, and a preceptor attestation. Per NRC Form 313A (AUT).

Method 2 — Alternate pathway

Current AU for other radiation therapy (e.g., oral iodine, brachytherapy, radium) — plus documentation of classroom and laboratory training, supervised work experience, supervised clinical case experience, and preceptor attestation per Form 313A.

Tip

Recency of training matters — generally, training and experience (including board certification) should have been obtained within the 7 years preceding the AU application. Physicians outside that window typically need to repeat the training pathway or document enough continuing education to bring it current.

For radiation oncologists board-certified after January 1, 2024, the ASTRO 'alternate pathway' may be used to demonstrate compliance with training and experience requirements without using board certification alone. Visit the ASTRO website for details.

References

10 CFR §35.390 — Training for use of unsealed byproduct material for which a written directive is required.
10 CFR §35.40 / §35.41 — Written directives.
NRC Form 313A (AUT) — Authorized User training and experience.
NRC Medical Uses Licensee Toolkit. www.nrc.gov/materials/miau/med-use-toolkit.html