How to Obtain Authorized User Status

This guide is provided as a resource and is intended for educational and informational purposes only and does not constitute legal advice. You should consult with appropriate legal counsel to determine its compliance with any applicable laws, rules or regulations. ASTRO assumes no responsibility for the accuracy of the below information.

Background: In April, the American Board of Radiology (ABR) notified the Nuclear Regulatory Commission (NRC) of their intent to terminate the NRC-recognition of all ABR certification processes after December 31, 2023.

What does this mean? As of January 1, 2024, any radiation oncologist who is interested in becoming an Authorized User (AU) under 10 CFR 35, Medical Use of Byproduct Material, must obtain AU status via the “alternate pathway.”

For Trainees

Ensure that in addition to maintaining meticulous records, complete with preceptor attestations, your training program fills out both NRC form 313A (AUT) and form 313A (AUS) and provides those to you upon graduation. This information must also be accessible to you indefinitely. At the bottom of this page, we include links to state radiation control programs, as well as any applicable forms (where available). We believe that most Agreement States will accept the NRC forms, however, we recommend that where practicable, you have the state forms filled as well.
Ask your training program to make you an AU under their license.

This will be dependent on what type of license your facility has, and the structure of your training program. The first step would be to discuss this with your program director, your radiation safety officer (RSO) and your radiation safety committee.

For broad scope licenses: the radiation safety officer (RSO) and the radiation safety committee can add you to the license. See articles in ASTROnews Winter 2023: How to set up Your Radiopharmaceutical Therapy Program in Three Steps and Bringing Radiopharmaceuticals to Your Practice: Regulatory Requirements.

For limited scope or single use licenses: your RSO will need to file a license amendment with the state (for Agreement States) or the NRC. This may not be the most efficient route as it may take time for the NRC or state to approve the license amendment, but it is worth considering.

For Training Programs

Ensure that you are maintaining meticulous records, complete with preceptor attestations. Both NRC form 313A (AUT) and form 313A (AUS) should be filled out and provided to trainees upon graduation. Copies of records and completed NRC forms should be kept and made available to former trainees indefinitely.
Make your trainees AUs under your license.

This will be dependent on what type of license your facility has and the structure of your training program.

For broad scope licenses: the RSO and Radiation Safety Committee will make the determination and add the new AU to the license.

For limited scope or single use license: your RSO will need to file a license amendment with the state (for Agreement States) or the NRC. This may not be the most efficient route as it may take time for the NRC or state to approve the license amendment, but it is worth considering.

The Alternate Pathway

This information in this section is intended for educational and informational purposes only and does not constitute legal advice. You should consult with appropriate legal counsel to determine its compliance with any applicable laws, rules or regulations. ASTRO assumes no responsibility for the accuracy of the below information.

The “alternate pathway” is how radiation oncologists become AUs without using board certification to prove compliance with training and experience (T&E) requirements. Each section of 10 CFR 35, Medical Use of Byproduct Material has specific T&E requirements that must be met before AU status is granted.

35.390 Training for use of unsealed byproduct material for which a written directive is required: 700 hours of T&E, including 200 hours of classroom and laboratory training in basic radionuclide handling techniques, and 500 hours of work experience. The physician must receive written attestation.

More Information (35.390)

Classroom and laboratory training: Radiation physics and instrumentation; radiation protection; mathematics pertaining to the use and measurement of radioactivity; chemistry of byproduct material for medical use; and radiation biology.

Work experience: ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys; Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters; Calculating, measuring, and safely preparing patient or human research subject dosages; Using administrative controls to prevent a medical event involving the use of unsealed byproduct material; Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; Administering dosages of radioactive drugs to patients or human research subjects from the three categories in this paragraph: Oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I–131, for which a written directive is required; Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I–131; Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required.

Written attestation: Has obtained written attestation that the individual has satisfactorily completed the requirements in 35.390. The attestation must be obtained from either: a preceptor AU who meets the requirements and has experience in administering dosages in the same dosage category(ies); or a residency program director.

35.490 Training for use of manual brachytherapy sources: 700 hours of T&E that includes 200 hours of classroom and laboratory training and 500 hours of work experience, under the supervision of an AU. The physician must receive written attestation.

More Information (35.490)

Classroom and laboratory training: Radiation physics and instrumentation; radiation protection; mathematics pertaining to the use and measurement of radioactivity; and radiation biology.

Work experience: Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys; Checking survey meters for proper operation; Preparing, implanting and removing brachytherapy sources; Maintaining running inventories of material on hand; Using administrative controls to prevent a medical event involving the use of byproduct material; Using emergency procedures to control byproduct material; and has completed 3 years of supervised clinical experience in radiation oncology, under an AU who meets the requirements.

Written attestation: Has obtained written attestation that the individual has satisfactorily completed the requirements in 35.490 and is able to independently fulfill the radiation safety-related duties as an AU of manual brachytherapy sources. The attestation must be obtained from either: a preceptor AU who meets the requirements or a residency program director.

35.690 Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units: 700 hours of T&E that includes 200 hours of classroom and laboratory training and 500 hours of work experience. The physician must receive written attestation.

More Information (35.690)

Classroom and laboratory training: Radiation physics and instrumentation; radiation protection; mathematics pertaining to the use and measurement of radioactivity; and radiation biology.

Work experience: Reviewing full calibration measurements and periodic spot-checks; preparing treatment plans and calculating treatment doses and times; using administrative controls to prevent a medical event involving the use of byproduct material; implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console; checking and using survey meters; and selecting the proper dose and how it is to be administered; and has completed 3 years of supervised clinical experience in radiation therapy, under an authorized user who meets the requirements.

Written attestation: Has obtained written attestation that the individual has satisfactorily completed the requirements in 35.690 and is able to independently fulfill the radiation safety-related duties as an authorized user of each type of therapeutic medical unit. The attestation must be obtained from either: a preceptor AU who meets the requirements or a residency program director.

35.1000 Other medical uses of byproduct material or radiation from byproduct material: specific T&E requirements are found in the guidance documents associated with the relevant technology. Guidance documents can be found on the NRC website. Contact your state radiation protection program (for Agreement States) or the NRC for specific instructions.

What is needed to obtain AU status

The NRC provides extensive guidance in NUREG-1556, Volume 9, Revision 3, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses.

Applicants must have successfully completed the applicable T&E criteria described in 10 CFR 35 within seven years preceding the date of the application.
If the applicant completed training more than seven years preceding the date of the application, they must submit documentation of related continuing education and experience since completing the required training and experience.
1. Acceptable continuing education and experience for physicians include the following:
  1. successful completion of classroom and laboratory review courses that include radiation safety practices relative to the proposed type of authorized medical use (this review may include various types of instruction, including online training, as long as the subject matter relates to radiation safety and safe handling of byproduct material for the uses requested).
  2. practical and laboratory experience with patient procedures using radioactive material for the same use(s) for which the applicant is requesting authorization.
  3. practical and laboratory experience under the supervision of an AU at the same or another licensed facility that is authorized for the same use(s) for which the applicant is requesting authorization.
  4. for therapy devices, experience with the therapy unit and/or comparable linear accelerator experience and completion of an in-service review of operating and emergency procedures relative to the therapy unit to be used by the applicant.
Applicants must use the most current version of the applicable NRC Form 313A. Verify that the most current version is being used by checking the “Expires” date in the right, top-hand corner of the form.
1. Use NRC Form 313A (AUS) for manual brachytherapy sources (10 CFR 35.400), ophthalmic use of strontium-90 (10 CFR 35.400), remote afterloader unit(s) (10 CFR 35.600), teletherapy unit(s) (10 CFR 35.600) and gamma stereotactic radiosurgery unit(s) (10 CFR 35.600).
2. Use NRC Form 313A (AUT) for use of unsealed byproduct material for which a written directive is required (10 CFR 35.300), oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries) (10 CFR 35.300), oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries) (10 CFR 35.300), and parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required.

State Regulatory Resources

Below please find links to state radiation protection programs relevant forms (where available)

This list is a state-by-state set of links which are subject to frequent change. The list is intended as a resource only, and ASTRO does not represent that it is all inclusive. The list is current as of February 2023, but ASTRO assumes no responsibility for the accuracy and timeliness of any information linked from this page. Users should verify that they are viewing the most up-to-date regulations or forms; ultimate responsibility for compliance with the regulations lies with the user.

Alabama