Temporary Policies for Compounding Certain Parenteral Drug Products; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Temporary Policies for Compounding Certain Parenteral Drug Products." As of October 10, 2024, pursuant to the Public Health Service Act (PHS Act), Department of Health and Human Services (HHS) Secretary Becerra has determined that public health emergencies (PHEs) exist as a result of the consequences of Hurricane Helene in the States of North Carolina, Florida, Georgia, Tennessee, and South Carolina, and as a result of the consequences of Hurricane Milton in the State of Florida. In late September 2024, Hurricane Helene had a devastating impact on one of the largest manufacturers of certain intravenous and peritoneal dialysis solutions in the United States. This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain parenteral drug products by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities.