FDA Issues Warning About Compounding Pharmacies Using Supplement-Grade Glutathione for IV Products

The U.S. Food and Drug Administration (FDA) issued a warning about compounding pharmacies using dietary supplement-grade glutathione as an ingredient in sterile compounded injectables.

The warning comes as increased regulatory attention is being placed on the blurring boundaries between dietary supplements and other product categories that fall under different regulatory classifications; IV-grade glutathione, for instance, is required to meet different specification, quality, and documentation standards for the intended use.

FDA reported that 30 patients experienced adverse events following the administration of intravenous glutathione alone or in combination with other ingredients. The glutathione was compounded by different compounding pharmacies, all of which obtained their glutathione from Medisca Inc., which was labeled as dietary supplement grade, making it inappropriate to use in injectable drugs.

Two pharmacies in Texas conducted recalls related to elevated endotoxin levels in their glutathione injectable drugs, FDA reported.

The adverse events reported included fever, chills, pain, dizziness, signs of shock, and sepsis-like symptoms, some of which resulted in hospitalizations. These symptoms were consistent with exposure to excessive endotoxin levels; other symptoms can include muscle pain, headache, nausea, vomiting, low blood pressure, and death, FDA reported.

FDA reported that Medisca Inc. told the agency that it sent its U.S. customers a warning not to use dietary supplement-grade glutathione in the compounding of injectable drugs. The agency urged compounders that received dietary supplement-grade glutathione from Medisca to contact customers and instruct them to discontinue the use of their IV glutathione products.

FDA noted that compounders are responsible for ensuring that all components in injectable drugs are appropriate for intended use, and not dietary supplement-grade ingredients, which may contain impurities and contaminants including endotoxins that make them harmful when administered as an injectable drug. “Compounders should not rely on testing alone to ensure the quality of the drug. Quality should be built into every step of the compounding process, including ingredient sourcing, stock solution preparation, and finished drug release.”