S.C. Code Regs. § § 61-63.IV.C.RHA 4.27

Current through Register Vol. 48, 12, December 27, 2024

Section 61-63.IV.C.RHA 4.27 - Determination of Dosages of Unsealed Byproduct Material for Medical Use

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

4.27.2 For a unit dosage, this determination must be made by--

4.27.2.1 Direct measurement of radioactivity; or

4.27.2.2 A decay correction, based on the activity or activity concentration determined by--

4.27.2.2.1 A manufacturer or preparer licensed under RHA 2.7.5 or equivalent NRC requirements;

4.27.2.2.2 An 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

4.27.2.2.3 A PET radioactive drug producer licensed under Part 2 of this Regulation or equivalent Agreement State requirements.

4.27.3 For other than unit dosages, this determination must be made by--

4.27.3.1 Direct measurement of radioactivity;

4.27.3.2 Combination of measurement of radioactivity and mathematical calculations; or

4.27.3.3 Combination of volumetric measurements and mathematical calculations, based on the measurement made by:

4.27.3.3.1 A manufacturer or preparer licensed under Part 2 of this Regulation or equivalent Agreement State requirements; or

4.27.3.3.2 A PET radioactive drug producer licensed under Part 2 of this Regulation or equivalent Agreement State requirements.

4.27.4 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.

4.27.5 A licensee shall retain a record of the dosage determination required by this section in accordance with RHA 4.95.

S.C. Code Regs. § 61-63.IV.C.RHA 4.27