November 4, 2024: The FDA continues to work for patient safety

The U.S. Food and Drug Administration (FDA) reminded compounders only to use sterile ingredients to manufacture sterile drugs, specifically calling out the use of food-grade nicotinamide adenine dinucleotide (NAD+) to make intravenous supplements. Food grade NAD+ that is not properly processed may contain microbes and endotoxins, and patients who use it have reported severe chills, shaking, vomiting and fatigue that are consistent with endotoxin exposure.

The FDA also warned patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, California, which ceased operations in September. After a patient complained about black particulate in a vial of semaglutide it had distributed, inspectors determined that Fullerton had been using non-sterile ingredients to make its injectables.

Reuters reports that after lengthy shortages, the FDA has listed all doses of Novo Nordisk’s semaglutide products, Wegovy and Ozempic, as available. Some of the supply problems may have been the result of manufacturing issues: FiercePharma reports that FDA inspectors filed a Form 483 report to a Danish facility that makes Novo’s semaglutide and insulin products because it was not following procedures to ensure quality and sterility.