WAC 246-240-107   Determination of dosages of unsealed radioactive material for medical use.  (1) A licensee shall determine and record the activity of each dosage before medical use.

     (2) For a unit dosage, this determination must be made by:

     (a) Direct measurement of radioactivity; or

     (b) A decay correction, based on the activity or activity concentration determined by:

     (i) A manufacturer, producer, or preparer licensed under WAC 246-235-100 or equivalent U.S. NRC or agreement state requirements; or

     (ii) An agreement state or U.S. NRC licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug (IND) protocol accepted by FDA.

     (3) For other than unit dosages, this determination must be made by:

     (a) Direct measurement of radioactivity;

     (b) Combination of measurement of radioactivity and mathematical calculations; or

     (c) Combination of volumetric measurements and mathematical calculations, based on the measurement made by a manufacturer, producer, or preparer licensed under WAC 246-235-100 or equivalent agreement state requirements.

     (4) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than twenty percent.

     (5) A licensee shall retain a record of the dosage determination required by this section in accordance with WAC 246-240-569.



[Statutory Authority: RCW 70.98.050 and 70.98.080. 09-06-003, § 246-240-107, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. 06-05-019, § 246-240-107, filed 2/6/06, effective 3/9/06.]