Are pre-filled saline/heparin flush syringes treated as prescription drugs or prescription devices?
Consistent with the federal Food and Drug Administration’s August 2006 designation of pre-filled syringes of saline/heparin (100 U/ml or 10 U/ml) flush as medical devices, the North Carolina Board of Pharmacy will likewise regulate such flushes as medical devices under the Pharmacy Practice Act. ——————————————————————————————- Q: What is the proper procedure for providing heparin, saline, sterile water for irrigation and hydration fluids to home health agencies? A: The agency may store sterile normal saline for irrigation and sterile water for irrigation at the clinical offices. A physician’s order for one of the above for a specific patient serves as a prescription. If sterile normal saline for irrigation or sterile water for irrigation are ordered, it is not necessary for a pharmacist to dispense them. However, if the solution is left in a patient’s home, it must be labeled according to pharmacy regulations. Ideally, the lab
