ASHP Updates IV Fluid Shortage Resource; FDA Announces Compounding Flexibilities

Today, ASHP updated its clinical and operational suggestions for small- and large-volume fluid management and conservation. The revisions include additional conservation considerations, the addition of a frequently asked questions section, and additional links to external resources and recommendations by other professional organizations.

The Food and Drug Administration (FDA) also announced temporary policies for 503A pharmacy compounders and 503B outsourcing facilities that may support their efforts to address fluid shortages. Details of the flexibilities are included on FDA’s Hurricane Helene resource page. ASHP advocated for additional compounding flexibility to address the fluid shortages, with the understanding that compounding may help fill gaps but will not be sufficient to solve the problem.

Here’s what else members should know about the availability of IV fluids and peritoneal dialysis in the wake of Hurricane Helene and Hurricane Milton:

• The FDA authorized importation of certain products to address the IV solutions shortage. The FDA has provided a list of temporary importation sources.
• FDA has not yet extended expiration dates for products. The agency is recommending that hospitals do not throw away products nearing their expiration dates and encouraging organizations to contact manufacturers for stability data of IV fluids. To contact Baxter, email: [email protected].
• FDA announced that dextrose 70%, Lactated Ringer’s solution, and peritoneal dialysis fluids are now included on FDA’s shortage list.
• The B. Braun manufacturing site and distribution center in Daytona Beach, Florida, a supplier of IV fluids, are intact after Hurricane Milton. The company announced it would resume operations on Friday and keep stakeholders updated.
• Learn about fluid conservation solutions from the recording of this webinar offered earlier this week by the End Drug Shortages Alliance.
• The American Hospital Association has compiled new resources, including ASHP’s conservation recommendations.
• The Administration for Strategic Preparedness and Response has activated the Emergency Prescription Assistance Program (EPAP) for uninsured residents of North Carolina, Tennessee, and Georgia. Uninsured patients who’ve lost medications or medical supplies due to Hurricane Helene may request a free 30-day supply of certain prescription medications or medical supplies at any EPAP-participating pharmacy while the EPAP is active.

ASHP remains committed to ensuring members have the most up-to-date information on the availability of medications in the wake of Hurricane Helene and Hurricane Milton. We will continue to update members as additional information becomes available. Consult our Drug Shortages Resource Center for additional information on current shortages and for resources to assist in managing and conserving inventory at your practice site.