FDA:

• Meeting daily for situation awareness

• IV solution shortage started before the hurricane – information found on two website

  • Pre-hurricane – General drug database shortage website - https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages o Hurricane

  • Helene website - https://www.fda.gov/drugs/updates-2024-hurricane-season/hurricane-helene-baxters-manufacturing-recovery-north-carolina

• 23 sites (domestic and international) working to help combat this shortage

• Flexibility on policies for the impacted solutions

• Temporary importation regulations lifted to help get product in the country

• Expediting shelf-life data on extending for affected products – please reach out. Do not throw out!

• Have discretion to be able to be make any regulatory discussions

• Emergency guidance put out for the compounding pharmacies to the 24-hour rule. It can be found on the FDA Hurricane Helene website.

• As information becomes available with the Baxter facility, FDA will review and expedite the approval to get the facility back online.

ASPR

• Working with Baxter to bring in product from international sites – 200 flights by the end of the year

  • Working with border control/customs to expedite importation process

• Assisting other vendors to continue ramped up production of the affected products.

• Looking at other supply chain providers to ensure no other products are affected.

• Allocation Conservation is still in place on solutions in this disruption

• SNS does not maintain IV solutions – not an option for this situation · Factsheet: https://www.hhs.gov/about/news/2024/10/18/fact-sheet-hhs-continues-action-increase-access-supply-iv-fluids-hurricane-helene.html

Baxter

• NC facility has made tremendous progress since the storm

• Scaled up production at all other facilities across the globe

• Prioritizing vulnerable populations

• Working with providers to modify prescriptions to help ensure patients get what they need while conserving products

• There is a 1-2 weeks lag in product distribution at the moment.

• Now have a process for peds allocations. Email the Baxter Hurricane Helene email for guidance.

  • hurricanehelenesupport@baxter.com

  • 5-7 days for approval and distribution

• Opening up to new patients in the coming weeks. Asking for coordination with the Baxter team as it will be a slow process.

  • Goal – be back at pre-hurricane Helene levels by the end of the year

CDC

• Working with healthcare facilities to get creative on alternative ways to conserve products – use oral options, etc.