12VAC5-481-1820: Determination of dosages of unsealed radioactive material for medical use

A. Licensees shall determine and record the activity of each dosage before medical use.

B. For a unit dosage, this determination shall be made by:

1. Direct measurement of the radioactivity; or

2. A decay correction based on activity or activity concentration determined by:

a. A manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state requirements;

b. An agency, NRC, or another agreement state licensee for use in research in accordance with Radioactive Drug Research Committee-approved protocol or Investigational New Drug (IND) protocol accepted by FDA; or

c. A PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements.

C. For other than unit dosages, this determination shall be made by:

1. Direct measurement of radioactivity;

2. Combination of measurement of radioactivity and mathematical calculations; or

3. Combination of volumetric measurements and mathematical calculations, based on the measurement made by:

a. A manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state requirements; or

b. A PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements.

D. Unless otherwise directed by the authorized user, licensees may not use a dosage if the dosage does not fall within the prescribed dosage range or the dosage differs from the prescribed dosage by more than 20%.