Section 1950. Use of unsealed radioactive material for which a written directive is required

Article 6. Unsealed Byproduct Material - Written Directive Required

Licensees may use any unsealed radioactive material prepared for medical use and for which a written directive is required 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 another 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; or an individual under the supervision, as specified in 12VAC5-481-1710, of an ANP or the 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 an investigational new drug (IND) protocol accepted by U.S. Food and Drug Administration (FDA); or

4. Prepared by the licensee for use in research in accordance with an IND protocol accepted by FDA.

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.