La. Admin. Code tit. 33 § XV-732

Current through Register Vol. 50, No. 11, November 20, 2024

Section XV-732 - Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentrations

A. A licensee shall not administer to humans a radiopharmaceutical containing:

1. more than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m (0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m);

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

3. 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).

B. A licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall measure the molybdenum-99 concentration or the rubidium-82 concentration in each eluate or extract from a generator to demonstrate compliance with Subsection A of this Section.

C. A licensee who must measure molybdenum concentration shall retain a record of each measurement for three years. The record shall include, for each elution or extraction of technetium-99m, the measured activity of the technetium expressed in millicuries (megabecquerels), the measured activity of molybdenum expressed in microcuries (kilobecquerels), the ratio of the measures expressed as microcuries of molybdenum per millicurie of technetium (kilobecquerels of molybdenum per megabecquerel of technetium), the date of the test, and the initials of the individual who performed the test.

D. The licensee shall notify the Office of Environmental Compliance by telephone at (225) 765-0160 and the distributor of the generator within seven calendar days after discovery that an eluate exceeded the permissible concentration specified in LAC 33:XV.732.A at the time of generator elution. The telephone report to the department shall include:

1. the manufacturer;

2. model number, and serial number (or lot number) of the generator;

3. the results of the measurement;

4. the date of the measurement;

5. whether dosages were administered to patients or human research subjects;

6. when the distributor was notified; and

7. the action taken.

E. By an appropriate method listed in LAC 33:I.3923, the licensee shall submit a written report to the Office of Environmental Compliance within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution.

1. The written report shall include:

a. the action taken by the licensee;

b. the patient dose assessment;

c. the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects;

d. the probable cause and an assessment of failure in the licensee's equipment, procedures, or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and

e. the information in the telephone report as required by Subsection D of this Section.

La. Admin. Code tit. 33, § XV-732

Promulgated by the Department of Environmental Quality, Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:2589 (November 2000), amended by the Office of the Secretary, Legal Division, LR 40:291 (February 2014), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 471857 (12/1/2021), Amended by the Office of the Secretary, Legal Affairs Division, LR 4962 (1/1/2023).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq. and 2104.B.