Article 5. Unsealed Byproduct Material – Written Directive Not Required
12VAC5-481-1900. Use of unsealed radioactive material for uptake, dilution, and excretion studies for which a written directive is not required.
Article 5
Unsealed Byproduct Material – Written Directive Not Required
Except for quantities that require a written directive under 12VAC5-481-1720, licensees may use any unsealed radioactive material prepared for medical use for uptake, dilution, or excretion studies that is:
1. Obtained from a manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state regulations or a PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements;
2. Excluding PET radionuclides, prepared by (i) an ANP; (ii) a physician who is an AU and who meets the requirements specified in 12VAC5-481-1940 or 12VAC5-481-1980 and 12VAC5-481-1940 3 a 1; or (iii) an individual under supervision, as specified in 12VAC5-481-1710;
3. Obtained from and prepared by an agency, NRC, or another agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigation New Drug (IND) protocol accepted by FDA; or
4. Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigation New Drug (IND) protocol accepted by FDA for use in research.
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.
12VAC5-481-1910. Training for uptake, dilution, and excretion studies.
Except as provided in 12VAC5-481-1780, licensees shall require an authorized user of unsealed radioactive material for the uses authorized under 12VAC5-481-1900 to be a physician:
1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC, the agency, or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
a. Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies as described in subdivisions 3 a (1) through 3 a (2) (f) of this section; and
b. Pass an examination administered by diplomates of the specialty board that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or
2. Who is an authorized user under 12VAC5-481-1940, 12VAC5-481-1980, or equivalent NRC or other Agreement state requirements; or
3. Who has:
a. Completed 60 hours of training and experience, including a minimum of eight hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies. The training and experience shall include the following:
(1) Classroom and laboratory training in the following areas:
(a) Radiation physics and instrumentation;
(b) Radiation protection;
(c) Mathematics pertaining to the use and measurement of radioactivity;
(d) Chemistry of radioactive material for medical use; and
(e) Radiation biology; and
(2) Work experience under the supervision of an authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1940, 12VAC5-481-1980, or equivalent NRC or other Agreement state requirements, involving:
(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(c) Calculating, measuring, and safely preparing patient or human research subject dosages;
(d) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;
(e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and
(f) Administering dosages of radioactive drugs to patients or human research subjects; and
b. Obtained written attestation that the individual has satisfactorily completed the requirements in subdivision 3 a of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 12VAC-481-1900. The attestation must be obtained from either:
(1) A preceptor authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1940, or 12VAC5-481-1980 or equivalent NRC or other agreement state requirements; or
(2) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1940, or 12VAC5-481-1980 or equivalent NRC or other agreement state requirements and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in subdivision 3 a of this section.
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.
12VAC5-481-1920. Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required.
Except for quantities that require a written directive under 12VAC5-481-1720, licensees may use any unsealed radioactive material prepared for medical use for imaging and localization studies that is:
1. Obtained from a manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state requirements or a PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements;
2. Excluding production of PET radionuclides, prepared by an ANP; a physician who is an authorized user (AU) and who meets the requirements specified in 12VAC5-481-1940, or 12VAC5-481-1980 and 12VAC5-481-1940 3 a (1) (g); or an individual under the supervision, as specified in 12VAC5-481-1710, of an ANP or a physician who is an AU;
3. Obtained from and prepared by an agency, NRC, or another agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an IND protocol accepted by FDA; or
4. Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA.
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.
12VAC5-481-1930. Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
A. Licensees may not administer to humans a radiopharmaceutical that contains:
1. More than 0.15 µCi of molybdenum-99 per mCi of technetium-99m (0.15 kBq of molybdenum-99 per MBq of technetium-99m); or
2. More than 0.02 µCi of strontium-82 per mCi of rubidium-82 chloride (0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection) or more than 0.2 µCi of strontium-85 per mCi of rubidium-82 (0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection).
B. A licensee that uses molybdenum-99/technetium-99m for preparing a technetium-99m radiopharmaceautical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with subsection A of this section.
C. A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with subsection A of this section.
D. If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and strontium-85 concentrations, the licensee shall retain a record of each measurement in accordance with 12VAC5-481-2070 K.
E. The licensee shall report any measurement that exceeds the limits in subsection A of this section at the time of generator elution in accordance with 12VAC5-481-2080 D.
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; Errata, 39:5 VA.R. 943 October 24, 2022.
12VAC5-481-1940. Training for imaging and localization studies.
Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) of unsealed radioactive material for the uses authorized under 12VAC5-481-1920 to be a physician:
1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC, the agency, or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page; or
2. Who is an AU under 12VAC5-481-1980 and meets the requirements in subdivision 3 a (2) (g) of this section, or equivalent NRC or other Agreement state requirements; or
3. Who has:
a. Completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience shall include at a minimum:
(1) Classroom and laboratory training in the following areas:
(a) Radiation physics and instrumentation;
(b) Radiation protection;
(c) Mathematics pertaining to the use and measurement of radioactivity;
(d) Chemistry of radioactive material for medical use; and
(e) Radiation biology; and
(2) Work experience, under the supervision of an authorized user who meets the requirements in this section, 12VAC5-481-1780, or 12VAC5-481-1980 and subdivision 3 a (2) (g) of this section, or equivalent NRC or other Agreement state requirements. An authorized nuclear pharmacist who meets the requirements of 12VAC5-481-1770 or 12VAC5-481-1780 may provide the supervised work experience in subdivision 3 a (2) (g) of this section. Work experience must involve:
(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(c) Calculating, measuring, and safely preparing patient or human research subject dosages;
(d) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;
(e) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;
(f) Administering dosages of radioactive drugs to patients or human research subjects; and
(g) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclide purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and
b. Obtained written attestation that the individual has satisfactorily completed the requirements in subdivision 3 a of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 12VAC5-481-1900 and 12VAC5-481-1920. The attestation must be obtained from either:
(1) A preceptor authorized user who meets the requirements in this section, 12VAC5-481-1780, or 12VAC5-481-1980 and subdivision 3 a (2) (g) of this section, or equivalent NRC or other agreement state requirements; or
(2) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this section, 12VAC5-481-1780, or 12VAC5-481-1980 and subdivision 3 a (2) (g), or equivalent NRC or other agreement state requirements and concurs with the attestation provided by the residency program director. The residency training must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specific in subdivision 3 a of this section.
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.