Ariz. Admin. Code § R9-7-713 - Determination of Prescribed Dosages, and Possession, Use, and Calibration of Instruments

A. A licensee shall determine and record the activity of each dosage before medical use.

B. For a unit dosage, this determination shall be made by:

1. Direct measurement of radioactivity; or

2. Decay correction, based on the activity or activity concentration determined by:

a. A manufacturer or preparer licensed under R9-7-311 or equivalent NRC or Agreement State requirements; or

b. A Department, a NRC, or an Agreement State 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 or;

c. A PET radioactive drug producer licensed under 1 R9-7-311 or equivalent NRC or Agreement State requirements.

C. For other than unit dosages, this determination shall be made by:

1. Direct measurement of radioactivity;

2. Combination of measurement of radioactivity and mathematical calculations; or

3. Combination of volumetric measurements and mathematical calculations based on the measurement made by a manufacturer or preparer licensed under R9-7-311, or equivalent NRC or Agreement State requirements.

D. 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.

E. A licensee shall retain a record of the dosage determination required by this Section for Department inspection for three years.

F. For direct measurements performed in accordance with subsection (B)(1), a licensee shall possess and use instrumentation to measure the activity of the dosage before it is administered to each patient or human research subject.

G. A licensee shall calibrate the instrumentation required in subsection (F) in accordance with nationally recognized standards, the manufacturer's instructions, or the following procedures.

1. The procedures that may be followed are:

a. Check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use;

b. Test each dose calibrator for accuracy upon installation and at least annually thereafter by assaying at least two sealed sources containing different radio-nuclides whose activity the manufacturer has determined within 5 percent of its stated activity, whose activity is at least 10 microcuries for radium-226 and 50 microcuries for any other photon-emitting radio-nuclide, and at least one of which has a principal photon energy between 100 keV and 500 keV;

c. Test each dose calibrator for linearity upon installation and at least quarterly thereafter over a range from the highest dosage that will be administered to a patient or human research subject to 1.1 megabec-querels (30 microcuries);

d. Test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. The licensee shall keep a record of this test for the duration of the use of the dose calibrator;

e. Perform appropriate checks and tests required by this Section following adjustment or repair of the dose calibrator; and

f. Mathematically correct dosage readings for any geometry or linearity error that exceeds 10 percent if the dosage is greater than 10 microcuries and shall repair or replace the dose calibrator if the accuracy or constancy error exceeds 10 percent.

2. A licensee shall maintain the dose calibrator in accordance with this subsection, even though the dose calibrator is only used to "verify" a dosage prepared by a supplier authorized in subsection (B)(2).

3. A licensee shall maintain on file for Department review nationally recognized standards or manufacturer's instructions used to maintain a dose calibrator and meet the requirements of subsection (G).

H. A licensee shall calibrate the survey instruments before first use, annually, and following a repair that affects the calibration. A licensee shall:

1. Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source;

2. Calibrate two separated readings on each scale or decade that will be used to show compliance; and

3. Conspicuously note on the instrument the date of calibration.

I. A licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20 percent.

J. A licensee shall retain records of instrument calibration for three years following the calibration.

Notes

Ariz. Admin. Code § R9-7-713

New Section R9-7-713 recodified from R12-1-713 at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1).