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

2. (2) For a unit dosage, this determination must be made by:

   1. (a) Direct measurement of radioactivity; or

   2. (b) A decay correction, based on the activity or activity concentration determined by:

      1. 1. A manufacturer or preparer licensed under paragraph (10) of Rule 0400-20-10- .13 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or
      2. 2. An Agreement State or U.S. Nuclear Regulatory Commission licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug (IND) protocol accepted by Food and Drug Administration (FDA).
      3. 3. A PET radioactive drug producer licensed under paragraph (8) of Rule 0400-20- 10-.11 or equivalent Agreement State Requirements.

3. (3) For other than unit dosages, this determination must be made by:

   1. (a) Direct measurement of radioactivity;
   2. (b) Combination of measurement of radioactivity and mathematical calculations; or

   3. (c) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:

      1. 1. A manufacturer or preparer licensed under paragraph (10) of Rule 0400-20-10- .13 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, or
      2. 2. A PET radioactive drug producer licensed under paragraph (8) of Rule 0400-20- 10-.11 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements.
4. (4) 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.
5. (5) A licensee shall retain a record of the dosage determination required by this rule in accordance with Rule 0400-20-07-.89.

Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq. Administrative History: Original rule filed February 22, 2012; effective May 22, 2012.