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.

Drugs covered under the temporary guidance includes certain dextrose, sodium chloride, sterile water, Lactated Ringer's, and peritoneal dialysis solutions. According to the Centers for Disease Control and Prevention (CDC), Hurricane Helen severely damaged Baxter International’s North Cove facility in North Carolina, the largest manufacturer of peritoneal dialysis and intravenous solutions, which led it to issue a Health Alert Network (HAN) advisory.

"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," said FDA. "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.

"This policy is intended to remain in effect only for the duration of the supply disruption related to the above referenced PHEs, or for another period of time as FDA may announce," the agency added. “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."

Under the Food, Drug, and Cosmetics (FD&C) Act, outsourcing facilities are restricted from compounding drugs that are not on FDA's drug shortage list, and those that do are required to first have a patient-specific prescription. The facilities must also register with the agency and are overseen by its inspectors to ensure they comply with current good manufacturing practices (cGMP). However, considering the critical drug shortages caused by the hurricanes, regulators will use their enforcement discretion to allow compounders not registered as outsourcing facilities to make critical drugs in short supply if they meet certain requirements.

"Although FDA is monitoring the global pharmaceutical supply chain and working, within its authorities, with manufacturers of approved parenteral drug products to bolster supply, temporary flexibility is needed to help ensure that treatment options remain available to hospitals and health systems during this period," said FDA.

FDA encouraged hospitals and health systems to get drugs from outsourcing facilities as a first option but acknowledged that they may ultimately have difficulty getting adequate supplies of FDA-approved parenteral drug products or comparable products from outsourcing facilities. As a temporary measure, the agency said it will refrain from taking regulatory action against state-licensed pharmacies that are not registered as outsourcing facilities for compounding drugs to hospitals or health systems without a patient-specific prescription or for producing copies of commercially available drugs.

However, the facilities have to meet all five requirements the agency has listed, including the compounded drug has to be on its temporary drug shortage list; it is labeled with a default beyond use date (BUD); the compounding pharmacy and the hospital or health system are not owned and controlled by the same entity; the pharmacy has to notify the relevant state authority of its intention; and the compounder complies with certain sanitary, strength, quality, and purity requirements of the FD&C.

FDA also said that it temporarily won't take enforcement actions against outsourcing facilities for compounding drugs that are copies of approved drugs, for using bulk drug substances that are not on FDA's 503B Bulks List, or for not meeting cGMP requirements if they follow similar requirements.

Final guidance

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

Related topics

Recommended content

Welcome to the new RAPS Digital Experience