Special Edition: Compliance Monitor. Post Hurricane Helene and Milton
(10/14/2024)
Resources & Flexibilities to Assist with the Public Health Emergency in Florida
On October 8, 2024, HHS Secretary Xavier Becerra determined that a public health emergency exists in Florida and has existed since October 5, 2024. CMS is working closely with the state and federal partners to put these flexibilities in place to ensure those affected by this natural disaster have access to the care they need – when they need it most.
CMS stands ready to assist with resources and waivers to ensure hospitals and other facilities can continue to operate and provide access to care to those impacted by the consequences of the hurricane.
More Information:
- Current Emergencies webpage
TRACIE Express Update
Medical product shortages can follow hurricanes and other extreme weather incidents. Most recently, flooding due to Hurricane Helene inundated a Baxter International facility in North Carolina, one of the key intravenous (IV) fluid suppliers in the U.S. The new tipsheet Intravenous Fluid Shortage Strategies contains information that can help healthcare providers modify traditional practices and conserve product.
Letter to Health Care Leaders and Stakeholders on Impacts of Hurricane Helene from Secretary Becerra
The impacts of Hurricane Helene have led to the temporary supply disruption at the Baxter facility in Marion, North Carolina. The Baxter facility provides a significant portion of IV solutions, irrigation fluids, and peritoneal solutions to the U.S. medical system. There are currently shortages of normal saline IV fluids, normal saline irrigation fluid, sterile water irrigation, and dextrose 5% IV fluids that pre-date Hurricane Helene., The hurricane-related supply disruption at the Baxter facility will likely lead to further constraints for IV fluids. However, compounding of drugs on the FDA shortage list can be done in accordance with current requirements to help alleviate shortages [see Compounding when Drugs are on FDA’s Drug Shortages List | FDA]. In the coming weeks, supply may continue to be constrained, and we understand that certain products are on allocation; however, Baxter reported that they have resumed shipments to hospitals and dialysis providers and patients after the temporary hold last week, based on allocations as previously communicated. The inventory will be used to support current allocations in the short term, and they note that several of their global plants are scaling and ramping production to help meet U.S. needs. Other producers are expected to be able to continue to fulfill domestic orders within their allocation.
This is what you can expect in the coming months.
HHS is coordinating a USG-wide response to address supply chain disruptions. HHS is also working with public and private partners to support the supply chain while the Baxter facility is brought back to full operational capacity. FDA will continue working with Baxter to identify both potential products already in their system and alternative manufacturing sites, including for potential temporary imports. As alternatives are identified, FDA is expediting assessments of those options. FDA will also expedite consideration of any shelf-life extension requests manufacturers submit for short-dated products. FDA will continue to work with Baxter as they bring their plant back online and with other suppliers to increase supply.
FDA – Temp Policy for Compounding Certain Parenteral Drugs
The FDA has issued an immediately-in-effect guidance, Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of Hurricane Helene on Baxter International’s North Cove facility. The FDA also added three new drug products to the Drug Shortages Database as a result of Hurricane Helene. The agency now considers Dextrose 70% IV solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution to not be commercially available in adequate supply to meet national demand.
The FDA is working continuously to address the shortages and supply disruptions to ensure patients have access to certain parenteral drugs, including IV solutions. For the most recent information on drug and biologic products that were impacted by Hurricane Helene, please see FDA’s Baxter Recovery webpage.