Article 2. General Information
12VAC5-481-1670. General requirements.
Article 2
General Information
A. Licensees may conduct research involving human research subjects only if it uses the radioactive materials specified on its license for the uses authorized on its license.
B. If the research is conducted, funded, supported, or regulated by another agency that has implemented a policy for protection of human subjects, the licensee shall, before conducting research:
1. Obtain review and approval of the research from an authorized review board; and
2. Obtain informed consent, in writing, from the human research subject.
C. If the research will not be conducted, funded, supported, or regulated by another agency that has implemented an appropriate protection policy, licensees shall, before conducting research, apply for and receive a specific license amendment to its medical use license. The amendment request shall include a written commitment that licensees will, before conducting research:
1. Obtain review and approval of the research from an authorized review board; and
2. Obtain informed consent, in writing, from the human research subject.
D. Nothing in this section relieves licensees from complying with other requirements of this part.
E. Nothing in this part relieves licensees from complying with applicable FDA, federal, and other state requirements governing radioactive drugs or devices.
F. When a requirement in this part differs from the requirement in an existing license condition, the requirement in this part shall govern.
G. Licensees shall continue to comply with any license condition that requires it to implement procedures required by 12VAC5-481-2043 and 12VAC5-481-2046 until there is a license amendment or renewal that modifies the license condition.
H. Each record required by this part shall be legible throughout the specified retention period. The record may be the original, a reproduced copy, or a microform if the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications shall include all pertinent information such as stamps, initials, and signatures. Licensees shall maintain adequate safeguards against tampering with and loss of records.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register 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.
12VAC5-481-1680. 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.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register 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.
12VAC5-481-1690. Notifications.
A. Licensees shall provide the agency the following information for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, an ophthalmic physicist, or an authorized medical physicist:
1. A copy of (i) the board certification, (ii) the written attestation signed by a preceptor, and (iii) the NRC or another Agreement state license;
2. The permit issued by a NRC master material licensee;
3. The permit issued by a broad scope licensee;
4. The permit issued by a NRC master material broad scope permittee; or
5. Documentation that only accelerator-produced radioactive materials, discrete sources of radium-226, or both, were used for medical use or in the practice of nuclear pharmacy at a government agency or federally recognized Indian tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC.
6. For individuals permitted to work within the 30-day time frame, the licensee shall also provide, as appropriate, verification of completion of:
a. Any additional case experience required in 12VAC5-481-1980 2 b (7) for an authorized user under 12VAC5-481-1950;
b. Any additional training required in 12VAC5-481-2040 A 4 for an authorized user under 12VAC5-481-2040 A; or
c. Any additional training required in 12VAC5-481-1760 A 3 for an authorized medical physicist.
B. A licensee shall notify the agency no later than 30 days after:
1. An authorized user, an authorized nuclear pharmacist, a radiation safety officer, an associate radiation safety officer, an ophthalmic physicist, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change;
2. The licensee permits an authorized user or an individual qualified to be a radiation safety officer, under 12VAC5-481-1750 and 12VAC5-481-1790, to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer in accordance with 12VAC5-481-1700 C;
3. The licensee's mailing address changes;
4. The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in 12VAC5-481-500 B; or
5. The licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used in accordance with either 12VAC5-481-1900 or 12VAC5-481-1920 if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area.
C. The licensee shall send the documents required in this section to the appropriate address identified in 12VAC5-481-150.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register 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; Volume 37, Issue 25, eff. January 14, 2022.