Section 1680. Licensing and exemptions

A. A person may manufacture, produce, acquire, receive, possess, prepare, use, or transfer radioactive material for medical use only in accordance with a specific license issued by the agency, the NRC, or another agreement state, or as allowed in subsection B of this section.

B. A specific license is not needed for an individual who:

1. Receives, possesses, uses, or transfers radioactive material in accordance with this part under the supervision of an authorized user as provided in 12VAC5-481-1710, unless prohibited by license condition; or

2. Prepares unsealed radioactive material for medical use in accordance with this part under the supervision of an authorized nuclear pharmacist or authorized user as provided in 12VAC5-481-1710, unless prohibited by license condition.

C. An application shall be signed by the applicant's or licensee's management.

D. An application for a license for medical use of radioactive material as described in 12VAC5-481-1900, 12VAC5-481-1920, 12VAC5-481-1950, 12VAC5-481-2010, 12VAC5-481-2020, 12VAC5-481-2040 B, and 12VAC5-481-2060 shall be made by:

1. Filing a completed and signed application for medical use; and

2. Submitting procedures required by 12VAC5-481-2043 and 12VAC5-481-2046, as applicable.

E. A request for a license amendment or renewal shall be made by:

1. Submission of a license amendment may be completed by submitting in letter format including all necessary documentation;

2. Submission for a license renewal shall be completed by submitting a completed and signed renewal application for medical use; and

3. Submitting procedures required by 12VAC5-481-2043 and 12VAC5-481-2046, as applicable.

F. In addition to the requirements in subsections D and E of this section, submittal of a license application or amendment for medical use of radioactive material as described in 12VAC5-481-2060 shall also include information regarding any radiation safety aspects of the medical use of the material that is not otherwise addressed in this part, including but not limited to, the following specific information:

1. Radiation safety precautions and instructions;

2. Training and experience of proposed users;

3. Methodology for measurement or dosages or doses to be administered to patients or human research subjects;

4. Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety; and

5. Any other information requested by the agency in its review of the application.

G. An applicant that satisfies the requirements specified in 12VAC5-481-470 may apply for a specific license of broad scope. Licensees possessing a Type A specific license of broad scope for medical use, issued under 12VAC5-481-470, are exempt from:

1. The provisions of subsection E of this section regarding the need to file an amendment to the license for medical use of radioactive material, as described in 12VAC5-481-2060;

2. Additions to or changes in any authorized user, authorized nuclear pharmacist, or authorized medical physicist;

3. Additions to or changes in the areas of use at the addresses identified in the application or on the license;

4. The provisions of 12VAC5-481-1690 A;

5. The provisions of 12VAC5-481-1690 for an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist;

6. The provisions of 12VAC5-481-1690 B 5;

7. The provisions of 12VAC5-481-1740.

H. The agency shall issue a license for medical use of radioactive material if:

1. The applicant has filed the appropriate application form in accordance with the instructions in this subsection and subsections D, F, G, and I of this section;

2. The applicant has paid any applicable fee as provided in 12VAC5-490;

3. The agency finds the applicant equipped and committed to observe the safety standards established by the agency in this part for the protection of the public health and safety; and

4. The applicant meets the requirements of 12VAC5-481-450.

I. The agency shall issue a license for mobile medical service if the applicant:

1. Meets the requirements of subsection H of this section and 12VAC5-481-1880; and

2. Assures that individuals or human research subjects to whom unsealed radioactive material or radiation from implants containing radioactive material will be administered may be released following treatment in accordance with 12VAC5-481-1870.

J. The agency may, upon application of any interested person or upon its own initiative, grant exemptions from the regulations in this part that it determines are authorized by law and will not endanger life, property, or the common defense and security and are otherwise in the public interest.

Historical Notes

Derived from Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Statutory Authority

§ 32.1-229 of the Code of Virginia.