Nebraska Administrative Code
Topic - HEALTH AND HUMAN SERVICES SYSTEM
Title 180 - CONTROL OF RADIATION
Chapter 7 - MEDICAL USE OF RADIOACTIVE MATERIAL
Section 180-7-031 - DETERMINATION OF DOSAGES OF UNSEALED RADIOACTIVE MATERIAL FOR MEDICAL USE

Universal Citation: 180 NE Admin Rules and Regs ch 7 ยง 031

Current through September 17, 2024

031.01 DOSAGE ACTIVITY. A licensee must determine and record the activity of each dosage prior to medical use.

031.02 UNIT 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.

031.03 OTHER 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.

031.04 DOSAGE 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.

031.05 RECORD RETENTION. A licensee must retain a record of the dosage determination required by 180 NAC 7 according to 180 NAC 7-093.

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