Or. Admin. Code § 333-116-0180

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-116-0180 - Determination of Dosages of Unsealed Radioactive Material for Medical Use

A licensee must:

(1) Assay, within 30 minutes before medical use, the activity of each radiopharmaceutical dosage that contains more than 370 kilobecquerels (10 uCi) of an alpha-, beta-, or photon-emitting radionuclide;

(2) For a dosage of an alpha- or beta-emitting radionuclide prepared by the licensee, this determination must be made by direct measurement or by a combination of measurements and calculations.

(3) A licensee must not use a dosage if the dosage differs from the prescribed dosage by more than 20 percent, unless authorized in writing by an authorized user.

(4) Retain a record of the assays required by this rule in accordance with OAR 333-100-0057. The record must contain the:

(a) Generic name, trade name or abbreviation of the radiopharmaceutical, its lot number and expiration dates and the radionuclide;

(b) Patient's name and identification number if one has been assigned;

(c) Prescribed dosage and activity of the dosage at the time of assay or a notation that the total activity is less than 370 kilobecquerels (10 uCi);

(d) Date and time of the assay;

(e) Date and time of administration; and

(f) Initials of the individual who performed the assay.

Or. Admin. Code § 333-116-0180

HD 1-1991, f. & cert. ef. 1-8-91; PH 3-2003, f. & cert. ef. 3-27-03; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 8-2018, minor correction filed 01/30/2018, effective 1/30/2018

Statutory/Other Authority: ORS 453.635

Statutes/Other Implemented: ORS 453.605 - 453.807