General requirements
Standing up an Ac-225 program is an exciting step that brings real operational obligations. Meeting the licensing, safety, facility, and staffing requirements is what makes the program safe for patients and staff — and what makes it auditable when the regulator visits.
Minimum requirements
To establish and operate a targeted alpha therapy program, an institution typically needs to meet baseline requirements across three pillars:
Licenses & protocols
- Obtain (or amend) a specific RAM license for medical use covering Ac-225
- Develop written procedures for receipt, handling, administration, decay, and waste
- Document a written-directive workflow and recordkeeping per 10 CFR Part 35
Space & equipment
- Designated hot lab, administration room, and post-administration restroom that meet regulatory standards
- Alpha-capable survey instruments (ZnS scintillation) and a low-background alpha counter for wipes
- Shielded transport, vial, and syringe equipment sized for daughter gammas (Bi-213)
Staff & training
- Authorized User (AU) meeting NRC §35.390 (or alternate pathway) for parenteral administration with written directive
- Authorized Medical Physicist (AMP) and qualified Radiation Safety Officer (RSO)
- Trained nuclear medicine technologists, nursing, and patient-navigation support
Licensing tends to be the longest lead item. It can help to sequence the regulatory work first — in parallel with site selection — so a hot lab build doesn't outpace the license amendment.
The information in this section is intended to help practitioners build appropriate care pathways for patients receiving alpha-emitting radiopharmaceuticals. It does not establish a legal standard of care; institutions are responsible for complying with all applicable federal, state, and local requirements by establishing their own policies, procedures, and guidance.