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Frequently Asked Questions for Pharmacists on Sterile Normal Saline/Sterile Water

Q: Are pre-filled saline/heparin flush syringes treated as prescription drugs or prescription devices?

A: 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 labeling should be done by a pharmacist. It is not necessary for the clinical offices to obtain any type of permit issued by the Board of Pharmacy. Sterile water and sterile normal saline may be administered by the nurse with a physician's order as long as the unlabeled container is not left in the patient's home.


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