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.