RAML application: overview
Guidance for obtaining a RAM license for medical use from the NRC is covered in their Program-Specific Guidance About Medical Use Licenses Final Report (NUREG-1556, Vol. 9, Rev. 3). The NRC RAM license (RAML) application uses NRC Form 313 — but the application can vary by state, since the NRC directly regulates only select states.
Administration of Ac-225-based radioligand therapies — like other radioligand therapies (e.g., PLUVICTO, LUTATHERA) — falls under 10 CFR Part 35, specifically Subpart E, because targeted alpha therapy administration requires the use of unsealed byproduct material for which a written directive is required. Agreement States may have their own regulations, but those regulations must align with NRC guidelines; states cannot be less restrictive than the NRC.
Requirements vary between limited scope and broad scope licenses, and the right fit usually depends on the range of radionuclides and uses your program needs. For specifics, the NRC or your Agreement State program is the best source.
Where to get the application
NRC Form 313
The standard NRC application for a materials license. Used directly in NRC-regulated states and as a reference for Agreement State applications. Available at www.nrc.gov.
State-specific applications
Agreement States may have their own application packages. Confirm with the state regulator which form to use before drafting; submitting the wrong form delays the file date.
- NUREG-1556, Vol. 9, Rev. 3.
- NRC Form 313 — Application for Materials License.
- NRC Agreement States. www.nrc.gov/about-nrc/state-tribal/agreement-states.html