PDFWAC 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 NRC or agreement state requirements; or
(ii) An agreement state or NRC licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug 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 20 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 70A.388.040 and 70A.388.110. WSR 22-19-084, § 246-240-107, filed 9/20/22, effective 10/21/22. Statutory Authority: RCW 70.98.050. WSR 13-11-021, § 246-240-107, filed 5/7/13, effective 6/7/13. Statutory Authority: RCW 70.98.050 and 70.98.080. WSR 09-06-003, § 246-240-107, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. WSR 06-05-019, § 246-240-107, filed 2/6/06, effective 3/9/06.]