Feds take action on Hurricane-wracked medical supply chain with wartime powers, drug compounding guidance

Editor's Note

The Biden administration has invoked wartime powers to speed rebuilding of intravenous fluid (IV) manufacturing capacity, CBS News reported October 15, four days after the US Food and Drug Administration (FDA) took steps to combat drug shortages.

Both efforts are in response to devastation wrought by Hurricane Helene, which led to flooding that shuttering a critical IV manufacturing plant in North Carolina. Another storm, Hurricane Milton, which made landfall in Florida two weeks later.

According to CBS News, 60% of the nation’s IV supplies depended on production from the plant. In invoking the Defense Production Act—previously used during the COVID-19 pandemic—the federal government is pushing Baxter, the medical supplier that runs the plant, “to the front of the line for a contractor needed for construction.” Officials from the federal Administration for Strategic Preparedness and Response  “are now looking into other ways that the powers might be able to accelerate rebuilding or help other domestic manufacturers ramp up.”

Under FDA’s emergency temporary guidance, the agency says it will not pursue regulatory action against compounding pharmacies and outsourcing facilities, Regulatory News reported October 14. The move is meant to ensure patients can access the drugs, which include certain dextrose, sodium chloride, sterile water, Lactated Ringer's, and peritoneal dialysis solutions.

According to FDA, "This policy is intended to remain in effect only for the duration of the supply disruption” related to declared public health emergencies. “As relevant needs and circumstances evolve, FDA intends to update, modify, or withdraw the policies in this guidance and the drug products that are the subject of this policy."