Section 61-05-01-06 - Minimum equipment requirementsEach pharmacy providing radiopharmaceutical services shall have the following equipment:
1. Area radiation monitor which is stationary and away from other activity.2. Dose calibrator and well counter.3. Portable survey meter, capable of measuring up to two thousand mR/hr for determining contamination and for other physic procedures.4. Sufficient quantity of lead bricks, lead plates, leaded glass of high density, and leaded or tungsten syringe shields.5. Refrigerator with freezer with temperature-monitoring capabilities.6. Class A prescription balance or balance of greater sensitivity.7. Single-channel or multichannel scintillation counter.8. Sink with hot and cold running water.9. Wipe test counter capable of detecting 0.005 microcuries of the radionuclides in question.10. Chromatographic equipment.11. Annually calibrated fume hood, if handling volatile radioactive materials.12. Chemical exhaust hood, if handling large quantities of chemicals.13. Electronic balance or class A prescription balance.14. Lighted microscope or hemocytometer, or both.15. ISO class 5 laminar flow-dispensing hood.16. Forceps or tongs for remote handling of material.17. Hotplate or heat block, or both.18. Class II biosafety cabinet for handling blood samples for labeling.20. Other equipment necessary for radiopharmaceutical services provided as required by the state board of pharmacy. The state board of pharmacy recognizes that the equipment needed will depend on the type of radiopharmaceutical services offered. Variations for required equipment may be granted by the state board of pharmacy.
N.D. Admin Code 61-05-01-06
Effective August 1, 1983; amended effective October 1, 2012.General Authority: NDCC 28-32-02, 43-15-10(9), 43-15-10(11), 43-15-10(12), 43-15-10(13), 43-15-10(14), 43-15-36
Law Implemented: NDCC 43-15-10(9), 43-15-10(11), 43-15-10(12), 43-15-10(13), 43-15-10(14), 43-15-36