License maintenance
Maintaining a current and accurate RAM license is the responsibility of the licensee. Any modification to the information provided in the original application requires a formal amendment request — and importantly, changes cannot be implemented until the amendment has been officially reviewed and issued by the regulatory authority.
Amendments
When an amendment is required
Amendments must be submitted for most material changes — including adding a new radionuclide (e.g., Ac-225), changing personnel such as the RSO or AUs, increasing the authorized quantity of RAM, changing the facility address, changing the manufacturer when named on the license, or updating certain procedures.
Renewals
Licensees are responsible for filing renewal documentation, which consists of all information required for initial licensure. The renewal application must be submitted in proper form no less than 30 days prior to the license expiration date. A licensee may be cited for a violation if RAM is possessed under an expired license.
Audits and inspections
State regulators and the NRC may perform inspections and audits, sometimes with advance notice and sometimes unannounced. Maintain inspection-ready records for written directives, training, surveys, dosimetry, waste, and procedure sign-offs.
Consider adding Ac-225 to your amendment package as a discrete line item — with quantities, intended use, and the AU(s) authorized to administer it. Bundling it under a generic 'therapeutic radiopharmaceuticals' authorization tends to slow review and invite additional RAIs.
- 10 CFR §30.36 — Expiration and Termination of Licenses.
- NUREG-1556, Vol. 9, Rev. 3.