Following the effects of recent hurricanes, including the closure of a Baxter IV fluid manufacturing plant in North Carolina, the Food and Drug Administration (FDA) on Oct. 11 released guidance that covers temporary policies for compounding certain parenteral drug products (such as IV fluids). This guidance, effective immediately, describes the FDA’s regulatory and enforcement priorities regarding such products by outsourcing facilities, as well as by state-licensed pharmacies and federal facilities not registered with the FDA as outsourcing facilities. This policy is intended to remain in effect only for the duration of the current supply disruption caused by the hurricanes or for another period announced by the FDA.
