Or. Admin. R. 333-116-0330

Current through Register Vol. 63, No. 8, August 1, 2024

Section 333-116-0330 - Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentration

(1) A licensee must not administer to humans a radiopharmaceutical containing more than 0.15 kBq (0.15 uCi) of molybdenum-99 per MBq (mCi) of technetium-99m; or

(2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per millicurie of rubidium-82).

(3) A licensee that uses molybdenum-99/technetium-99 generators for preparing technetium-99m radiopharmaceuticals must measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with section (1) of this rule.

(4) A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with section (1) of this rule.

(5) A licensee who must measure molybdenum concentration or strontium-82 and strontium-85 must retain a record of each measurement in accordance with OAR 333-100-0057. The record must include, for each elution or extraction of technetium-99m, the measured activity of the technetium expressed in MBq (mCi), the measured activity of the molybdenum expressed in kBq (uCi), the ratio of the measures expressed as kBq (uCi) of molybdenum per MBq (mCi) of technetium, the date of the test and the initials of the individual who performed the test.

(6) A licensee must report immediately to the Authority in accordance with OAR 333-116-1011 each occurrence of molybdenum-99 concentration exceeding the limits specified in section (1) of this rule.

Or. Admin. R. 333-116-0330

HD 1-1991, f. & cert. ef. 1-8-91; 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 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 21-2018, minor correction filed 02/01/2018, effective 2/1/2018; PH 81-2021, amend filed 11/19/2021, effective 11/23/2021

Statutory/Other Authority: ORS 453.635

Statutes/Other Implemented: ORS 453.605 - 453.807