Q: Does saline for wound irrigations have to be dispensed by a pharmacist with patient specific labels?
A: No. The FDA in September 1996 determined that saline used for wound irrigation is a medical device and does not have to be dispensed by a pharmacist with patient specific labels. However, saline used for instillation into the body, i.e., when used for a central line, or foley irrigation, or reconstituting a medication for instillation into the body, is still considered a drug and must be dispensed by a pharmacist with patient specific labels.