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.