Section 180-7-031 - DETERMINATION OF DOSAGES OF UNSEALED RADIOACTIVE MATERIAL FOR MEDICAL USE031.01DOSAGE ACTIVITY. A licensee must determine and record the activity of each dosage prior to medical use.031.02UNIT DOSAGE DETERMINATION. For unit dosages, this determination must be made by:(A) Direct measurement of radioactivity; or(B) A decay calculation, based on the activity or activity concentration determined by: (i) A manufacturer or preparer licensed according to 180 NAC 3-014.10 or equivalent NRC or Agreement State requirements;(ii) A Department, NRC, or Agreement State licensee for use in research according to a Radioactive Drug Research Committee-approved protocol or an Investigation New Drug (IND) protocol accepted by the FDA; or(iii) A positron emission tomography (PET) radioactive drug producer licensed in 180 NAC 3-010.11 or equivalent NRC or Agreement State requirements.031.03OTHER THAN UNIT DOSAGE. 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: (i) A manufacturer or preparer licensed according to 180 NAC 3-014.10 or equivalent provision of the NRC or Agreement State; or(ii) A PET radioactive drug producer licensed in 180 NAC 3-010.11 or equivalent NRC or Agreement State requirements.031.04DOSAGE RANGE. 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 twenty percent.031.05RECORD RETENTION. A licensee must retain a record of the dosage determination required by 180 NAC 7 according to 180 NAC 7-093.180 Neb. Admin. Code, ch. 7, § 031
Amended effective 11/3/2020Amended effective 6/14/2023