Section R12-1-713. Determination of Prescribed Dosages, and Pos- session, Use, and Calibration of Instruments

A.      A licensee shall determine and record the activity of each dos- age 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 con- centration determined by:

a.         A manufacturer or preparer licensed under R12-1- 311 or equivalent NRC or Agreement State require- ments; or

b.        An Agency, NRC, or 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 R12-1-311 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 mathe- matical calculations; or

3.        Combination of volumetric measurements and mathemat- ical calculations based on the measurement made by a manufacturer or preparer licensed under R12-1-311, 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 pre- scribed dosage range or if the dosage differs from the pre- scribed dosage by more than 20 percent.

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

F.       For direct measurements performed in accordance with sub- section (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 sub- section (F) in accordance with nationally recognized stan- dards, 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 ded- icated check source at the beginning of each day of use;

b.        Test each dose calibrator for accuracy upon installa- tion and at least annually thereafter by assaying at least two sealed sources containing different radio- nuclides whose activity the manufacturer has deter- mined 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 installa- tion 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 vol- ume configurations for which it will be used. The licensee shall keep a record of this test for the dura- tion 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 accor- dance with this subsection, even though the dose calibra- tor is only used to “verify” a dosage prepared by a supplier authorized in subsection (B)(2).

3.        A licensee shall maintain on file for Agency 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 calibra- tion. 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 calibra- tion.

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

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

Historical Note

New Section adopted by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by

final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2). Section repealed; new Section made by final rulemaking at 13 A.A.R. 1217, effective May 5, 2007 (Supp. 07-1). Amended by final rulemaking at 20

A.A.R. 324, effective March 8, 2014 (Supp. 14-1).