USA – FDA issues emergency compounding guidance to address drug shortages due to recent hurricanes

Following the devastation caused by hurricanes in the US southeast, the Food and Drug Administration has issued an emergency temporary guidance for compounding pharmacies to address drug shortages caused by the natural disasters. The agency says it will refrain from using regulatory action against compounding pharmacies and outsourcing facilities to ensure patients can access the drugs.

On 10 October, the Department of Health and Human Services (HHS) declared a public health emergency (PHE) due to the aftermaths of Hurricanes Helene and Milton. The following day, FDA published a temporary guidance for compounders to help mitigate potential drug shortages due to the hurricanes and said it is working with manufacturers and alternative suppliers to increase the supply of critical drugs…