Tenn. Comp. R. & Regs. 0400-20-07-.30

Current through October 22, 2024

Section 0400-20-07-.30 - DETERMINATION OF DOSAGES OF UNSEALED RADIOACTIVE MATERIAL FOR MEDICAL USE

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

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

(a) Direct measurement of radioactivity; or

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

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. 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. A PET radioactive drug producer licensed under paragraph (8) of Rule 0400-20-10-.11 or equivalent Agreement State Requirements.

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

(a) Direct measurement of radioactivity;

(b) Combination of measurement of radioactivity and mathematical calculations; or

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

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. 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) 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) A licensee shall retain a record of the dosage determination required by this rule in accordance with Rule 0400-20-07-.89.

Tenn. Comp. R. & Regs. 0400-20-07-.30

Original rule filed February 22, 2012; effective May 22, 2012.

Authority: T.C.A. §§ 68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq.